High Clopidogrel Dose Versus Prasugrel and Ticagrelor in High Reactive Stable Patients

Phase 3

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Prasugrel; Drug: Clopidogrel; Drug: Ticagrelor

• Registration Number: NCT01543932
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-21
• Study First Submitted QC: 2012-03-02
• Study First Posted: 2012-03-05
• Study Start: 2012-07
• Status Verified: 2013-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2013-12-10
• Last Update Posted: 2013-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prasugrel standard dose	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.
high clopidogrel dose	Clopidogrel	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.
Ticagrelor standard dose	Ticagrelor	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.

Primary Outcome Measures

Name	Time	Method
antiplatelet effect of standard dose of prasugrel or ticagrelor versus high dose clopidogrel in stable patients with high reactivity	30 days	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

Name	Time	Method
Bleeding (major, minor, or minimal)	45 days	Bleeding (major, minor, or minimal)
Major Adverse Cardiac Cerebrovascular Events	45 days	cardiovascular death, myocardial infarction, and stroke

Trial Locations

Locations (1)

Dept.of Cardiovascular Sciences,Policlinico Umberto I; 🇮🇹 Rome, Italy