DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: University of Roma La Sapienza
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Artery Disease

Intervention: Clopidogrel (Drug); Prasugrel (Drug); Ticagrelor (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: University of Roma La Sapienza

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.

Clinical Details

Official title: Comparison of Therapy With TICAGRELOR, Prasugrel and High Clopidogrel Dose in PCI Patients With High on Treatment Platelet Reactivity and Genotype Variation

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: antiplatelet effect of standard dose of prasugrel or ticagrelor versus high dose clopidogrel in stable patients with high reactivity

Secondary outcome:

Bleeding (major, minor, or minimal)

Major Adverse Cardiac Cerebrovascular Events

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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.

Locations and Contacts

Dept.of Cardiovascular Sciences,Policlinico Umberto I, Rome 000161, Italy
Additional Information

Starting date: July 2012
Last updated: December 10, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017