Clinical trial NCT01543932: High Clopidogrel Dose Versus Prasugrel and Ticagrelor in High Reactive Stable Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Disease
Keywords: antiplatelet effect
prasugrel
clopidogrel
stable angina
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2012-03-05
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: antiplatelet effect of standard dose of prasugrel or ticagrelor versus high dose clopidogrel in stable patients with high reactivity
timeFrame: 30 days
Secondary outcomes:
measure: Bleeding (major, minor, or minimal)
timeFrame: 45 days
measure: Major Adverse Cardiac Cerebrovascular Events
timeFrame: 45 days
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Dept.of Cardiovascular Sciences,Policlinico Umberto I
Study officials:
References:
citation: 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.