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

Myocardial Infarction Clinical Trial

— PRO-GR-4  

Official title:

Prasugrel in Comparison to Clopidogrel for Inhibition of Platelet Reactivity in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)and Presenting With High Platelet Reactivity, as Assessed With a Point of Care Assay, After 600mg Clopidogrel Loading Dose

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01338909
• Other study ID #: PATRASCARDIOLOGY-4
• Status: Completed
• Phase: Phase 3
• First received: April 15, 2011
• Last updated: September 29, 2011
• Start date: April 2011
• Est. completion date: September 2011

Study information

• Verified date: September 2011
• Source: University of Patras
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Age =18 years old

2. Patients with STEMI undergoing primary PCI with stenting

3. Platelet reactivity in PRU =235 2 hours post 600 mg clopidogrel loading dose

4. Informed consent obtained in writing

Exclusion Criteria:

1. 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.

2. Pregnancy

3. Breastfeeding

4. Inability to give informed consent or high likelihood of being unavailable until Day 5.

5. Cardiogenic shock

6. 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).

7. Unsuccessful PCI (residual stenosis > 30% or flow < ???? 3) or planned staged PCI in the next 5 days after randomization

8. Requirement for oral anticoagulant prior to the Day 5

9. Current or planned therapy with other thienopyridine class of ADP receptor inhibitors.

10. Known hypersensitivity to prasugrel or ticagrelor

11. History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months.

12. Other bleeding diathesis, or considered by investigator to be at high risk for bleeding on thienopyridine therapy.

13. Any previous history of ischemic stroke, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).

14. Thrombocytopenia (<100.000 / µL) at randomization

15. Anaemia (Hct <30%) at randomization

16. Polycythaemia (Hct > 52%) at randomization

17. Periprocedural IIb/IIIa inhibitors administration

18. Severe allergy to contrast agent, unfractionated heparin, enoxaparin or bivalirudin that cannot be adequately premedicated.

19. Recent (< 6 weeks) major surgery or trauma, including GABG.

20. 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.

21. INR>1.5 at randomization

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Prasugrel
Prasugrel 60mg immediate loading dose (Day 0)followed by 10mg/day starting from Day 1 until Day 5
• Clopidogrel
Clopidogrel 150mg/d starting from Day 1

Locations

Country	Name	City	State
Greece	Patras University Hospital	Patras

Sponsors (1)

Lead Sponsor	Collaborator
University of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet reactivity	Platelet Reactivity assessed by VerifyNow P2Y12 assay 24 hours post randomization	24 hours post randomization (Day 1)	No
Secondary	Platelet reactivity	Platelet Reactivity assessed by VerifyNow P2Y12 assay 2 hours post randomization	2 hours post randomization (Day 0)	No
Secondary	Platelet reactivity	Platelet reactivity assessed by VerifyNow P2Y12 assay 5 days post randomization	5 days post randomization (Day 5)	No
Secondary	Hyporesponsiveness rate	Hyporesponsiveness rate (PRU=235 assessed with the VerifyNow P2Y12 assay)2 hours post randomization	2 hours post randomization (Day 0)	No
Secondary	Hyporesponsiveness rate	Hyporesponsiveness rate (PRU=235 assessed with the VerifyNow P2Y12 assay)24 hours post randomization	24 hours post randomization (Day 1)	No
Secondary	Hyporesponsiveness rate	Hyporesponsiveness rate (PRU=235 assessed with the VerifyNow P2Y12 assay)5 Days post randomization	5 days post randomization (Day 5)	No