Therapy With High Clopidogrel Dose or Prasugrel Standard Dose Reduces the Platelet Reactivity in Patients With Genotype Variation RESET GENE Trial
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Purpose
Dual antiplatelet therapy with aspirin and Clopidogrel for at least one year is essential in patients following an acute coronary syndrome (ACS) or percutaneous coronary intervention (PCI) with drug eluting stent(s. Interindividual variability in platelet response to clopidogrel has been reported, with several mechanisms being implicated for high post-clopidogrel treatment PR. High on-treatment platelet reactivity (HTPR) is associated with an increased risk of adverse events after PCI. Studies in patients on chronic clopidogrel treatment are scarce, mainly in diabetic patients where HTPR is frequently present and independently predictive of adverse events. Optimization of platelet inhibition in patients with HTPR by increasing clopidogrel or alternatively, by more potent P2Y12 inhibitors is a controversial issue, mostly studied in post PCI patients, while no data exist, to the best of the investigators knowledge, in stable patients on chronic clopidogrel treatment. Therefore all HTPR patients, that will accept to participate, will be enrolled will randomize (Day 0) in a 1:1 ratio to either clopidogrel 150 mg a day, or prasugrel 10 mg a day, until Day 14 post randomization. A 14 ± 2 day visit will be performed for PR measurement and safety evaluation, with the blood sample being will be obtained 16-18 hours after the last study-drug dose, will follow by crossover directly to the alternate therapy for an additional 14 days without an intervening washout period. At Day 28 ± 2 patients will return for the clinical and laboratory assessment as did on Day 14 visit.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Coronary Syndrome |
Drug: Clopidogrel Drug: prasugrel |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | PhaRmacodynamic Effects of Switching thErapy in paTients With High on Treatment Platelet Reactivity and Genotype Variation: High Clopidogrel Dose Versus Prasugrel RESET GENE Trial |
- antiplatelet effect of standard dose of prasugrel versus high dose clopidogrel in stable patients with HTPR [ Time Frame: 14-28 days ] [ Designated as safety issue: Yes ]The primary aim will be to investigate the antiplatelet effect of standard dose of prasugrel versus high dose clopidogrel in stable patients with HTPR while receiving chronic clopidogrel treatment at the end of the 2 study periods (switching, crossover and post-crossover)
- Bleeding (major, minor, or minimal according to the TIMI study criteria) [ Time Frame: 14-28 days ] [ Designated as safety issue: Yes ]Bleeding (major, minor, or minimal according to the TIMI study criteria)
- Major Adverse Cardiac Cerebrovascular Events [ Time Frame: 14-28 days ] [ Designated as safety issue: Yes ]cardiovascular death, myocardial infarction, and stroke
| Enrollment: | 30 |
| Study Start Date: | October 2011 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: high clopidogrel dose
Patients will be randomized to this arm to receive before high clopidogrel dose and after crossover they will receive standard dose of prasugrel
|
Drug: Clopidogrel
Patient will be randomized to this intervention will receive in the first time the high clopidogrel dose and after 14 days we will change their therapy with standard dose of prasugrel (crossover).
Drug: prasugrel
Patient will be randomized to this intervention will receive in the first time the standard dose of prasugrel and after 14 days we will change their therapy with high dose of clopidogrel (crossover).
|
|
No Intervention: prasugrel standard dose
Patients will be randomized to this arm to receive before standard dose of prasugrel and after crossover they will receive high clopidogrel dose.
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- patients underwent to PCI
- lopidogrel resistance after Platelet reactivity blood test
Exclusion Criteria:
- history of bleeding diathesis
- chronic oral anticoagulation treatment
- contraindications to antiplatelet therapy
- PCI or coronary artery bypass grafting (CABG) <3 months
- hemodynamic instability
- platelet count <100,000/μl
- hematocrit <30%
- creatinine clearance <25 ml/min
- Patients with a history of stroke
- contraindication for prasugrel administration
- patients weighing <60 kg
- >75 years of age.
Contacts and Locations More Information
No publications provided by University of Roma La Sapienza
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Gennaro Sardella, Associate Professor in Cardiology, University of Roma La Sapienza |
| ClinicalTrials.gov Identifier: | NCT01465828 History of Changes |
| Other Study ID Numbers: | RESET GENE |
| Study First Received: | October 28, 2011 |
| Last Updated: | March 24, 2012 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by University of Roma La Sapienza:
|
antiplatelet effect prasugrel clopidogrel ACS |
Additional relevant MeSH terms:
|
Acute Coronary Syndrome Myocardial Ischemia Heart Diseases Cardiovascular Diseases Angina Pectoris Vascular Diseases Chest Pain Pain Signs and Symptoms Clopidogrel Ticlopidine Prasugrel Platelet Aggregation Inhibitors |
Hematologic Agents Therapeutic Uses Pharmacologic Actions Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Fibrinolytic Agents Fibrin Modulating Agents Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 22, 2013