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

• Sponsor: Gennaro Sardella (Other)
• Overall Status: Completed
• CT.gov ID: NCT01465828
• Collaborator: (none)
• Enrollment: 30
• Locations: 2
• Arms: 2
• Duration (Months): 3
• Patients Per Site: 15
• Patients Per Site Per Month: 5

Study Details

Study Description

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. 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 or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome	Drug: Clopidogrel; Drug: prasugrel	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (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
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. antiplatelet effect of standard dose of prasugrel versus high dose clopidogrel in stable patients with HTPR [14-28 days]

   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)

Secondary Outcome Measures

1. Bleeding (major, minor, or minimal according to the TIMI study criteria) [14-28 days]

   Bleeding (major, minor, or minimal according to the TIMI study criteria)

2. Major Adverse Cardiac Cerebrovascular Events [14-28 days]

   cardiovascular death, myocardial infarction, and stroke

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	Dept.of Cardiovascular Sciences,Policlinico Umberto I	Roma		Italy	00161
2	Dept.of Cardiovascular Sciences,Policlinico Umberto I	Rome		Italy	00155

Sponsors and Collaborators

• Gennaro Sardella

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gennaro Sardella, Associate Professor in Cardiology, University of Roma La Sapienza
• ClinicalTrials.gov Identifier: NCT01465828
• Other Study ID Numbers: RESET GENE
• First Posted: Nov 6, 2011
• Last Update Posted: Mar 27, 2012
• Last Verified: Nov 1, 2011

• Keywords provided by Gennaro Sardella, Associate Professor in Cardiology, University of Roma La Sapienza: antiplatelet effect; prasugrel; clopidogrel; ACS
• Additional relevant MeSH terms: Acute Coronary Syndrome; Clopidogrel; Prasugrel Hydrochloride

Study Results

No Results Posted as of Mar 27, 2012