Prasugrel in Comparison to Clopidogrel for Inhibition of Platelet Reactivity in Patients With ST-elevation Myocardial Infarction (STEMI) (PRO-GR-4)

University of Patras

Status and phase

Completed

Phase 3

Conditions

Myocardial Infarction

Treatments

Drug: Prasugrel

Drug: Clopidogrel

Study type

Interventional

Funder types

Other

Identifiers

NCT01338909

PATRASCARDIOLOGY-4

Details and patient eligibility

About

This is a single-center, randomized, single-blind, investigator-initiated, pharmacological study with a parallel design. Patients with ST elevation myocardial infarction undergoing primary percutaneous coronary intervention and presenting high platelet reactivity as assessed with the Verify Now P2Y12 assay-Accumetrics(Platelet Reactivity Units -PRU≥235) at 2 hours post-clopidogrel 600mg LD (Day 0), as assessed with the Verify Now P2Y12 assay, will be randomized after informed consent, in a 1:1 ratio to the following treatment groups:

Group Α: Clopidogrel 150mg per day,starting from Day 1 until Day 5 (5 days after randomization) Group Β: Prasugrel 60 mg immediate loading (on Day 0) followed by 10mg/day starting from Day 1 until Day 5 (5 days after randomization).

Platelet reactivity assessment will be performed 2 hours after randomization (Day 0), 24 h after randomization (Day 1) and on Day 5. Documentation of major adverse cardiac events (death, myocardial infarction, stroke, revascularization procedure with PCI or CABG)and serious adverse events (bleeding, other adverse events)will be performed until Day 5.

Enrollment

35 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥18 years old
Patients with STEMI undergoing primary PCI with stenting
Platelet reactivity in PRU ≥235 2 hours post 600 mg clopidogrel loading dose
Informed consent obtained in writing

Exclusion criteria

Treatment with other investigational agents (including placebo) or devices within 30 days prior to randomization or planned use of investigational agents or devices prior to the Day 5.
Pregnancy
Breastfeeding
Inability to give informed consent or high likelihood of being unavailable until Day 5.
Cardiogenic shock
Major periprocedural complications (death, stent thrombosis, vessel perforation, arrhythmias requiring cardioversion, temporary pacemaker insertion or intravenous antiarrhythmic agents, respiratory failure requiring intubation, vascular injury (pseudoaneurysm, arteriovenous shunt, retroperitoneal bleeding or hematoma >5 cm at the arterial catheter insertion site), major bleeding (need for bood transfusion or drop in haemoglobin post-PCI by ≥ 5 gr/ dl or intracranial bleeding).
Unsuccessful PCI (residual stenosis > 30% or flow < ΤΙΜΙ 3) or planned staged PCI in the next 5 days after randomization
Requirement for oral anticoagulant prior to the Day 5
Current or planned therapy with other thienopyridine class of ADP receptor inhibitors.
Known hypersensitivity to prasugrel or ticagrelor
History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months.
Other bleeding diathesis, or considered by investigator to be at high risk for bleeding on thienopyridine therapy.
Any previous history of ischemic stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
Thrombocytopenia (<100.000 / μL) at randomization
Anaemia (Hct <30%) at randomization
Polycythaemia (Hct > 52%) at randomization
Periprocedural IIb/IIIa inhibitors administration
Severe allergy to contrast agent, unfractionated heparin, enoxaparin or bivalirudin that cannot be adequately premedicated.
Recent (< 6 weeks) major surgery or trauma, including GABG.
Subjects receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors that cannot be discontinued for the duration of the study.
INR>1.5 at randomization