Clinical Trial Results. org Randomized Comparison of a High Clopidogrel Maintenance Dose in Patients with Diabetes Mellitus and Coronary Artery Disease:

Slides:

Advertisements

Similar presentations

August 30, 2009 at CET. Ticagrelor compared with clopidogrel in patients with acute coronary syndromes – the PLATO trial.

Advertisements

Clinical Trial Results. org Clopidogrel Use and Long-term Clinical Outcomes After Drug-Eluting Stent Implantation Eric Eisenstein, DBA; Kevin Anstrom,

Oral Antiplatelet Agents: A Cornerstone of Therapy for Atherothrombotic Disease Aspirin and clopidogrel: - Reduce the risks of myocardial infarction, ischemic.

Giuseppe Biondi-Zoccai Division of Cardiology, University of Turin, Turin, Italy.

Effect of Aspirin Dose on Platelet Reactivity in Diabetic Patients Effect of Aspirin Dose on Platelet Reactivity in Diabetic Patients Paul A. Gurbel, MD.

Aspirinn doses in diabetics - AngiolilloSlide 1 Davide Capodanno, MD, Aasita Patel, MD, Kodlipet Dharmashankar, MD, José Luis Ferreiro, MD, Masafumi Ueno,

Clinical Trial Results. org Pexelizumab for Acute ST-Elevation Myocardial Infarction in Patients Undergoing Primary Percutaneous Coronary Intervention.

University Medical Center Groningen Thrombus aspiration during primary PCI FZ Thrombus Aspiration during Percutaneous coronary intervention in Acute.

Impact of Platelet Reactivity on Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus and Coronary Artery Disease Dominick J. Angiolillo,

COURAGE: Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation Purpose To compare the efficacy of optimal medical therapy (OMT)

European guidelines on the management of stable coronary artery disease Key points & new position for Ivabradine and Trimetazidine ESC 2013 Montalescot.

Dominick J. Angiolillo, MD, PhD Director of Cardiovascular Research Assistant Professor of Medicine University of Florida College of Medicine – Jacksonville,

Pravastatin in Elderly Individuals at Risk of Vascular Disease Presented at Late Breaking Clinical Trials AHA 2002 PROSPER.

VBWG CHARISMA Clopidogrel for High Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance trial.

Jacqueline Saw, MD*, Danielle Brennan, MS †, Steven Steinhubl, MD ‡, Deepak L. Bhatt, MD †, Koon-Hou Mak, MD §, Keith Fox, MB^, and Eric J. Topol, MD #

0902CZR01NL537SS0901 RENAAL Altering the Course of Renal Disease in Hypertensive Patients with Type 2 Diabetes and Nephropathy with the A II Antagonist.

Point of Care Platelet Function Testing – Is There Still Value?

ACTIVE Clopidogrel plus Aspirin versus Aspirin in Patients Unsuitable for Warfarin.

Ticlopidine (Ticlid™) and Clopidogrel (Plavix™) Benedict R. Lucchesi, M.D., Ph.D. Department of Pharmacology University of Michigan Medical School.

Introduction Clopidogrel is metabolized by P450 (CYP)-isoenzymes: CYP 3A4/5, 1A2, 2B6, 2C9, and 2C19 1 Wide response variability and nonresponsiveness.

BARI 2D Trial BARI 2D Trial Presented at the American Diabetes Association (ADA) Annual Scientific Sessions 2009 in New Orleans The Bypass Angioplasty.

Antiplatelet Therapy Use and the Risk of Venous Thromboembolic Events in the Double-Blind Raloxifene Use for the Heart (RUTH) Trial C. Duvernoy 1, A. Yeo.

Prasugrel vs. Clopidogrel for Acute Coronary Syndromes Patients Managed without Revascularization — the TRILOGY ACS trial On behalf of the TRILOGY ACS.

High Versus Standard Clopidogrel Maintenance Dose After Percutaneous Coronary Intervention: Effects on Platelet Inhibition, Endothelial Function and Inflammation.

Avoiding Cardiovascular Events through COMbination Therapy in Patients LIving with Systolic Hypertension The First Outcomes Trial of Initial Therapy With.

Ten-Year Follow-up Survival of the Medicine, Angioplasty, or Surgery Study (MASS-II): a Randomized Controlled Clinical Trial of Therapeutic Strategies.

Rimonabant in Obesity Presented at American College of Cardiology Scientific Sessions 2004 Presented by Dr. Jean-Pierre Despres RIO LIPIDS Trial.

Antiplatelet Therapy for Reduction of Myocardial Damage During Angioplasty Study (ARMYDA-2) Trial ARMYDA-2 Trial Presented at The American College of Cardiology.

Aspirin Resistance: Significance, Detection and Clinical Management of This Real Phenomenon Webcast May 10 th, 2004 Sponsored by.

ARMYDA-4 (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) study Prospective, multicenter, randomized, double blind trial investigating.

Michael A. Nelson, MD 1 Michele D. Voeltz, MD 1 Frederick Feit, MD 2 A. Michael Lincoff, MD 3 Steven V. Manoukian, MD 1 1 Emory University School of Medicine.

SPARCL Stroke Prevention by Aggressive Reduction in Cholesterol Levels trial.

Vorapaxar for Secondary Prevention in Patients with Prior Myocardial Infarction Benjamin M. Scirica, MD, MPH On behalf of the TRA 2°P-TIMI 50 Steering.

Clinical Trial Results. org SAGE Trial Prakash Deedwania, MD; Peter H. Stone, MD; C. Noel Bairey Merz, MD; Juan Cosin-Aguilar, MD; Nevres Koylan, MD; Don.

Naotsugu Oyama, MD, PhD, MBA A Trial of PLATelet inhibition and Patient Outcomes.

Community Outreach to Reduce Disparities in Cardiovascular & Diabetes Morbidity & Mortality in the South Bronx Michael Alderman, MD Michelle Johnson, MD,

Clinical Trial Results. org Anti-Inflammatory Effects of Pioglitazone and/or Simvastatin in High Cardiovascular Risk Patients With Elevated High Sensitivity.

ADAPT-DES One-Year Results Assessment of Dual AntiPlatelet Therapy with Drug-Eluting Stents A Large-Scale, Multicenter, Prospective, Observational Study.

Clinical Trial Results. org Increased Risk in Patients with High Platelet Aggregation Receiving Chronic Clopidogrel Therapy Undergoing Percutaneous Coronary.

Name of the speaker: Germano DiSciascio I have the following potential conflicts of interest to report:  Consulting  Employment in industry  Stockholder.

ARMYDA-4 (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) study Germano Di Sciascio, MD, FACC, FESC Professor & Chairman of.

Slide Source: Lipids Online Slide Library ASTEROID Population at Baseline (n=507) Patients Completing (n=349) Patients Not Completing.

David J. Moliterno, MD, MPH Chief, Cardiovascular Medicine Professor & Vice-Chair of Medicine University of Kentucky Co-Director - Gill Heart Institute.

- Published online December 23, 2008 DOI: /S (08) Study sponsored and funded by Assistance Publique.

Allen Jeremias, Neal Kleiman, Deborah Nassif, Wen-Hua Hsieh, Michael Pencina, Kelly Maresh, Manish Parikh, Donald Cutlip, Ron Waksman, Steven Goldberg,

Long-Term Tolerability of Ticagrelor for Secondary Prevention: Insights from PEGASUS-TIMI 54 Trial Marc P. Bonaca, MD, MPH on behalf of the PEGASUS-TIMI.

Long-Term Tolerability of Ticagrelor for Secondary Prevention: Insights from PEGASUS-TIMI 54 Trial Marc P. Bonaca, MD, MPH on behalf of the PEGASUS-TIMI.

ARMYDA-4 (Antiplatelet therapy for Reduction of MYocardial Damage during Angioplasty) study Prospective, multicenter, randomized, double blind trial investigating.

Antiplatelet Therapy Use after Discharge among Acute Myocardial Infarction Patients with In-hospital Bleeding Tracy Y. Wang, MD, MHS, Lan Xiao, PhD, Karen.

Antiplatelet Therapy for Reduction of Myocardial Damage During Angioplasty Study (ARMYDA-2) Trial ARMYDA-2:ARMYDA-2:

Date of download: 6/1/2016 Copyright © The American College of Cardiology. All rights reserved. From: Patients With Poor Responsiveness to Thienopyridine.

Adapted from Angiolillo DJ et al. Am J Cardiol. 2006;97: Individual Response Variability to Dual Antiplatelet Therapy in the Steady State Phase of.

The JUPITER Trial Reference Ridker PM. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med. 2008;359:2195–2207.

Ten Year Outcome of Coronary Artery Bypass Graft Surgery Versus Medical Therapy in Patients with Ischemic Cardiomyopathy Results of the Surgical Treatment.

The SYMPHONY Trial Reference Reddan DN, et al. Renal function, concomitant medication use and outcomes following acute coronary syndromes. Nephrol Dial.

Date of download: 7/9/2016 Copyright © The American College of Cardiology. All rights reserved. From: Making Sense of Statistics in Clinical Trial Reports:

Lack of Evidence of a Clopidogrel – Statin Interaction in the CHARISMA Trial J Am Coll Cardiol 2007;50:291-5 Jacqueline Saw, MD*, Danielle Brennan, MS†,

Dominick J. Angiolillo, MD, PhD, FACC, FESC, FSCAI

Baseline characteristics and effectiveness results

Effect of Aspirin Dose on Platelet Reactivity in Diabetic Patients Paul A. Gurbel, MD Director, Sinai Center for Thrombosis Research Sinai Hospital.

Francesco Franchi, MD, Fabiana Rollini, MD, Jose Rivas Rios, MD, Andrea Rivas, MD, Malhar Agarwal, MD, Megha Kureti, MD, Deepa Nagaraju, MD, Mustafa Wali,

Figure 3 Ischaemic outcomes in the ST-segment elevation myocardial

Nat. Rev. Cardiol. doi: /nrcardio

Nat. Rev. Cardiol. doi: /nrcardio

Nat. Rev. Cardiol. doi: /nrcardio

Antiplatelet Therapy Use after Discharge among Acute Myocardial Infarction Patients with In-hospital Bleeding Tracy Y. Wang, MD, MHS, Lan Xiao, PhD, Karen.

Impact of Platelet Reactivity Following Clopidogrel Administration

Factor Xa Inhibitors in Coronary Artery Disease

Stephen J. Nicholls, MBBS, PhD; E

Update on the New Antiplatelet Agents:

Presentation transcript:

Clinical Trial Results. org Randomized Comparison of a High Clopidogrel Maintenance Dose in Patients with Diabetes Mellitus and Coronary Artery Disease: Results of the Optimizing Antiplatelet Therapy in Diabetes Mellitus (OPTIMUS) Study Dominick J. Angiolillo, MD, PhD; Steven B. Shoemaker, MD; Bhaloo Desai, PhD; Hang Yuan, PhD; Ronald K. Charlton, PhD; Esther Bernardo, BSc; Martin M. Zenni, MD; Luis A. Guzman, MD; Theodore A. Bass, MD; Marco A. Costa, MD, PhD Published online in Circulation January 29, 2007 OPTIMUS

Clinical Trial Results. org OPTIMUS: Background After treatment with clopidogrel, patients with type 2 diabetes mellitus have reduced platelet inhibition compared with patients who are not diabetic.After treatment with clopidogrel, patients with type 2 diabetes mellitus have reduced platelet inhibition compared with patients who are not diabetic. Recent studies have shown that type 2 diabetes mellitus patients have reduced response to P2Y 12 receptor antagonists, including clopidogrel, compared with nondiabetic subjects.Recent studies have shown that type 2 diabetes mellitus patients have reduced response to P2Y 12 receptor antagonists, including clopidogrel, compared with nondiabetic subjects. After treatment with clopidogrel, patients with type 2 diabetes mellitus have reduced platelet inhibition compared with patients who are not diabetic.After treatment with clopidogrel, patients with type 2 diabetes mellitus have reduced platelet inhibition compared with patients who are not diabetic. Recent studies have shown that type 2 diabetes mellitus patients have reduced response to P2Y 12 receptor antagonists, including clopidogrel, compared with nondiabetic subjects.Recent studies have shown that type 2 diabetes mellitus patients have reduced response to P2Y 12 receptor antagonists, including clopidogrel, compared with nondiabetic subjects. Angiolillo, et al. Circulation Jan; 115:

Clinical Trial Results. org OPTIMUS: Background (cont.) The aim of this pilot study was to evaluate the impact of a high maintenance dose of clopidogrel on platelet function profiles in type 2 diabetes mellitus patients with coronary artery disease (CAD) on long-term dual antiplatelet therapy who demonstrate suboptimal platelet inhibition.The aim of this pilot study was to evaluate the impact of a high maintenance dose of clopidogrel on platelet function profiles in type 2 diabetes mellitus patients with coronary artery disease (CAD) on long-term dual antiplatelet therapy who demonstrate suboptimal platelet inhibition. Angiolillo, et al. Circulation Jan; 115:

Clinical Trial Results. org OPTIMUS: Study Design  Primary Endpoint: Maximal ADP-induced platelet aggregation Group A 75 mg of Clopidogrel 30 days, n=20 Group A 75 mg of Clopidogrel 30 days, n=20 Group B 150 mg of Clopidogrel 30 days, n=20 Group B 150 mg of Clopidogrel 30 days, n=20 40 patients > 18 years with type 2 diabetes mellitus and coronary artery disease All patients also received aspirin (81 mg daily). Prospective. Randomized. Parallel-Group. 40 patients > 18 years with type 2 diabetes mellitus and coronary artery disease All patients also received aspirin (81 mg daily). Prospective. Randomized. Parallel-Group. R Platelet Function Testing Angiolillo, et al. Circulation Jan; 115: mg of Clopidogrel 30 days n=20 75 mg of Clopidogrel 30 days n=20 75 mg of Clopidogrel 30 days n=20 75 mg of Clopidogrel 30 days n=20 Platelet Function Testing At 60 days Platelet Function Testing At 60 days

Clinical Trial Results. org OPTIMUS: Demographics Characteristic75mg(n=20)150mg(n=20)P-value Age, y Male, n (%) 14 (70) 12 (60) 0.75 Race, n (%) White White Black Black Hispanic Hispanic 11 (55) 8 (40) 1 (5) 13 (65) 6 (30) 1 (5) Risk Factors, n (%) IDDM* IDDM* NIDDM† NIDDM† HbA1-C± HbA1-C± Smoking Smoking Hyperlipidemia Hyperlipidemia Hypertension Hypertension 6 (30) 14 (70) (20) 19 (95) 8 (40) 12 (60) (15) 18 (90) Angiolillo, et al. Circulation Jan; 115: *IDDM = Insulin-dependent diabetes mellitus; †NIDDM = Non-insulin-dependent diabetes mellitus; ±HbA1-C = hemoglobin A1C

Clinical Trial Results. org OPTIMUS: Demographics (Cont.) Characteristic75mg(n=20)150mg(n=20)P-value Risk Factors, n (%) Body Mass Index, kg/m 2 Body Mass Index, kg/m 2 Prior Myocardial Infarction Prior Myocardial Infarction Prior CABG Prior CABG Multivessel CAD Multivessel CAD (40) 4 (20) 15 (75) (35) 5 (25) 14 (70) Treatment, n (%) β-Blockers β-Blockers Nitrates Nitrates ACE inhibitors/ARB ACE inhibitors/ARB Lipid-lowering agents Lipid-lowering agents CYP3A4 metabolizing statin CYP3A4 metabolizing statin Non-CYP3A4 metabolizing statin Non-CYP3A4 metabolizing statin 17 (85) 6 (30) 13 (65) 17 (85) 1 (5) 16 (80) 8 (40) 14 (70) 15 (75) 4 (20) Angiolillo, et al. Circulation Jan; 115:

Clinical Trial Results. org Platelet aggregation was significantly reduced in the 150mg group compared with the 75mg group (63.1% vs. 52.3%, p=0.002)Platelet aggregation was significantly reduced in the 150mg group compared with the 75mg group (63.1% vs. 52.3%, p=0.002) (%) OPTIMUS Trial: Primary Endpoint n = 20 p = Study Time Point 2: Maximal ADP-Induced (20 µmol/L) Platelet Aggregation Angiolillo, et al. Circulation Jan; 115:

Clinical Trial Results. org At one month, patients assigned to the 150mg clopidogrel maintenance dose had an approximate 15% reduction in late (5 minutes) platelet aggregation after stimulus with 20 µmol/L ADPAt one month, patients assigned to the 150mg clopidogrel maintenance dose had an approximate 15% reduction in late (5 minutes) platelet aggregation after stimulus with 20 µmol/L ADP (%) (%) OPTIMUS Trial: Results n = 20 p < Late Adenosine Diphosphate Induced (20 µmol/L) Platelet Aggregation Angiolillo, et al. Circulation Jan; 115:

Clinical Trial Results. org OPTIMUS Trial: Results Patients assigned to 150mg dose returned to values comparable to those at baseline after a switch back to standard dosing (75mg)Patients assigned to 150mg dose returned to values comparable to those at baseline after a switch back to standard dosing (75mg) Study Time Point 3: Maximal ADP-Induced Platelet Aggregation (20µmol/L) n = 20 p=0.55 p=0.97 (%) n = 20 Angiolillo, et al. Circulation Jan; 115:

Clinical Trial Results. org OPTIMUS: Limitations The study did not account for performance of multiple significance tests or for potential correlation among various measures of platelet function.The study did not account for performance of multiple significance tests or for potential correlation among various measures of platelet function. This study was also not powered to evaluate the risk of bleeding with the use of high-dose clopidogrel in association with aspirin.This study was also not powered to evaluate the risk of bleeding with the use of high-dose clopidogrel in association with aspirin. The study was not designed to measure clinical outcomes and therefore the results are exploratory and should not be applied to clinical practice.The study was not designed to measure clinical outcomes and therefore the results are exploratory and should not be applied to clinical practice. The study did not account for performance of multiple significance tests or for potential correlation among various measures of platelet function.The study did not account for performance of multiple significance tests or for potential correlation among various measures of platelet function. This study was also not powered to evaluate the risk of bleeding with the use of high-dose clopidogrel in association with aspirin.This study was also not powered to evaluate the risk of bleeding with the use of high-dose clopidogrel in association with aspirin. The study was not designed to measure clinical outcomes and therefore the results are exploratory and should not be applied to clinical practice.The study was not designed to measure clinical outcomes and therefore the results are exploratory and should not be applied to clinical practice. Angiolillo, et al. Circulation Jan; 115:

Clinical Trial Results. org OPTIMUS: Summary This study demonstrates that the current recommended maintenance dose of clopidogrel is associated with a high incidence of suboptimal response for patients with type 2 diabetes mellitus and coronary artery disease.This study demonstrates that the current recommended maintenance dose of clopidogrel is associated with a high incidence of suboptimal response for patients with type 2 diabetes mellitus and coronary artery disease. Though some patients continued to show high platelet aggregation levels despite increased doses of clopidogrel, the study showed the overall biological effectiveness of a 150mg maintenance dose regimen compared with standard doses of 75mg in high risk patientsThough some patients continued to show high platelet aggregation levels despite increased doses of clopidogrel, the study showed the overall biological effectiveness of a 150mg maintenance dose regimen compared with standard doses of 75mg in high risk patients This study demonstrates that the current recommended maintenance dose of clopidogrel is associated with a high incidence of suboptimal response for patients with type 2 diabetes mellitus and coronary artery disease.This study demonstrates that the current recommended maintenance dose of clopidogrel is associated with a high incidence of suboptimal response for patients with type 2 diabetes mellitus and coronary artery disease. Though some patients continued to show high platelet aggregation levels despite increased doses of clopidogrel, the study showed the overall biological effectiveness of a 150mg maintenance dose regimen compared with standard doses of 75mg in high risk patientsThough some patients continued to show high platelet aggregation levels despite increased doses of clopidogrel, the study showed the overall biological effectiveness of a 150mg maintenance dose regimen compared with standard doses of 75mg in high risk patients Angiolillo, et al. Circulation Jan; 115: