Therapy With High Clopidogrel Dose or Prasugrel Standard Dose Reduces the Platelet Reactivity in Patients With Genotype Variation RESET GENE Trial

Acute Coronary Syndrome Clinical Trial

— RESET GENE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01465828
• Other study ID #: RESET GENE
• Status: Completed
• Phase: Phase 3
• First received: October 28, 2011
• Last updated: March 24, 2012
• Start date: October 2011
• Est. completion date: January 2012

Study information

• Verified date: November 2011
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

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).
• 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).

Locations

Country	Name	City	State
Italy	Dept.of Cardiovascular Sciences,Policlinico Umberto I	Roma
Italy	Dept.of Cardiovascular Sciences,Policlinico Umberto I	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Gennaro Sardella

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	antiplatelet effect of standard dose of prasugrel versus high dose clopidogrel in stable patients with HTPR	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)	14-28 days
Secondary	Bleeding (major, minor, or minimal according to the TIMI study criteria)	Bleeding (major, minor, or minimal according to the TIMI study criteria)	14-28 days
Secondary	Major Adverse Cardiac Cerebrovascular Events	cardiovascular death, myocardial infarction, and stroke	14-28 days