High Clopidogrel Dose Versus Prasugrel and Ticagrelor in High Reactive Stable Patients (TRIPLETE RESET)
This study is currently recruiting participants.
Verified December 2012 by University of Roma La Sapienza
Sponsor:
University of Roma La Sapienza
Information provided by (Responsible Party):
Gennaro Sardella, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01543932
First received: February 21, 2012
Last updated: December 4, 2012
Last verified: December 2012
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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) implantation. Interindividual variability in platelet response to Clopidogrel has been reported, with several mechanisms (intrinsic high platelet reactivity [PR], variability of the drug metabolism, and various drug interactions) being implicated for high post-Clopidogrel treatment PR. The investigators aim to perform a prospective, single-center, investigator-initiated, randomized, study to compare platelet inhibition by Prasugrel 10 mg/day, Ticagrelor (90 mg twice daily) and high-dose 150 mg/day Clopidogrel in patients with High on-treatment platelet reactivity (HTPR) with standard dose of Clopidogrel. Patients with HTPR (defined as area under curve-AUC ≥ 450 or > 45 Unit) and with loss-of-function allele CYP2C19*2 will be enrolled in the study and will be randomized (Day 0) in a 1:1:1 ratio, to either Clopidogrel 150 mg a day or Prasugrel 10 mg a day or Ticagrelor (90 mg twice daily) until Day-15 and-30 post randomization.
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Artery Disease |
Drug: Clopidogrel Drug: Prasugrel Drug: Ticagrelor |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparison of Therapy With TICAGRELOR, Prasugrel and High Clopidogrel Dose in PCI Patients With High on Treatment Platelet Reactivity and Genotype Variation |
Resource links provided by NLM:
Further study details as provided by University of Roma La Sapienza:
Primary Outcome Measures:
- antiplatelet effect of standard dose of prasugrel or ticagrelor versus high dose clopidogrel in stable patients with high reactivity [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]the antiplatelet effect in terms of level platelet reactivity (< 450 Area under the curve (AU*min)) of standard dose of Prasugrel (10 mg/day) either Ticagrelor (90 mg twice daily) versus high dose Clopidogrel (150 mg/day) in patients undergoing PCI with high reactivity
Secondary Outcome Measures:
- Bleeding (major, minor, or minimal) [ Time Frame: 45 days ] [ Designated as safety issue: Yes ]Bleeding (major, minor, or minimal)
- Major Adverse Cardiac Cerebrovascular Events [ Time Frame: 45 days ] [ Designated as safety issue: Yes ]cardiovascular death, myocardial infarction, and stroke
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2012 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Prasugrel standard dose
Patient will be randomized to this intervention will receive in the first time prasugrel and after 15 days and 30 days we will control the responsivness of the study drug.
|
Drug: Prasugrel
Patient will be randomized to this intervention will receive in the first time prasugrel and after 15 days and 30 days we will control the responsivness of the study drug.
|
|
Experimental: high clopidogrel dose
Patient will be randomized to this intervention will receive in the first time the high clopidogrel dose and after 15 days and 30 days we will control the responsivness of the study drug.
|
Drug: Clopidogrel
Patient will be randomized to this intervention will receive in the first time the double dose of clopidogrel and after 15 days and 30 days we will control the responsivness of the study drug.
|
|
Experimental: Ticagrelor standard dose
Patient will be randomized to this intervention will receive in the first time ticagrelor and after 15 days and 30 days we will control the responsivness of the study drug.
|
Drug: Ticagrelor
Patient will be randomized to this intervention will receive in the first time Ticagrelor and after 14 days and 28 days we will change their therapy with the high clopidogrel dose or Prasugrel (dual crossover).
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- patients underwent to percutaneous coronary intervention (PCI)
- clopidogrel 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543932
Contacts
| Contact: Gennaro Sardella, MD | +390649979035 | rino.sardella@uniroma1.it |
Locations
| Italy | |
| Dept.of Cardiovascular Sciences,Policlinico Umberto I | Recruiting |
| Rome, Italy, 000161 | |
| Contact: Rocco E Stio, MD rocco.stio@libero.it | |
| Sub-Investigator: Rocco E Stio, MD | |
| Principal Investigator: Gennaro Sardella, MD | |
Sponsors and Collaborators
University of Roma La Sapienza
More Information
No publications provided
| Responsible Party: | Gennaro Sardella, Associate Professor in Cardiology, University of Roma La Sapienza |
| ClinicalTrials.gov Identifier: | NCT01543932 History of Changes |
| Other Study ID Numbers: | TRIPLETE RESET |
| Study First Received: | February 21, 2012 |
| Last Updated: | December 4, 2012 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by University of Roma La Sapienza:
|
antiplatelet effect prasugrel clopidogrel stable angina |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Clopidogrel Ticlopidine Prasugrel Ticagrelor 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 21, 2013