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

NCT ID: NCT01543932

Last Updated: 2013-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-12-31

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.

Conditions

Coronary Artery Disease

Keywords

antiplatelet effect; prasugrel; clopidogrel; stable angina

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Prasugrel

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Clopidogrel

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Ticagrelor

Intervention Type: DRUG

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).

Interventions

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.

Intervention Type: 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.

Intervention Type: 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).

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Roma La Sapienza

OTHER

Sponsor Role: lead

Responsible Party

Gennaro Sardella

Associate Professor in Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dept.of Cardiovascular Sciences,Policlinico Umberto I

Rome, Rome, Italy

Countries

Italy

References

Sardella G, Calcagno S, Mancone M, Lucisano L, Pennacchi M, Stio RE, Placentino F, Di Roma A, Cavallo E, Palmirotta R, Guadagni F, Fedele F. Comparison of therapy with Ticagrelor, Prasugrel or high Clopidogrel dose in PCI patients with high on treatment platelet reactivity and genotype variation. TRIPLETE RESET trial. Int J Cardiol. 2015 Sep 1;194:60-2. doi: 10.1016/j.ijcard.2015.05.085. Epub 2015 May 15. No abstract available.

Reference Type: DERIVED

PMID: 26011265 (View on PubMed)

Other Identifiers

TRIPLETE RESET

Identifier Type: -

Identifier Source: org_study_id