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

Primary Purpose

Myocardial Infarction

Status

Completed

Phase

Phase 3

Locations

Greece

Study Type

Interventional

Intervention

Prasugrel

Clopidogrel

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring prasugrel, clopidogrel, primary percutaneous coronary intervention, high platelet reactivity

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Patras University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prasugrel

Clopidogrel

Arm Description

Prasugrel 60mg immediate loading dose (Day 0)followed by 10mg/day starting from Day 1 until Day 5

Clopidogrel 150mg/day starting from Day 1 until Day 5

Outcomes

Primary Outcome Measures

Platelet reactivity

Platelet Reactivity assessed by VerifyNow P2Y12 assay 24 hours post randomization

Secondary Outcome Measures

Platelet reactivity

Platelet Reactivity assessed by VerifyNow P2Y12 assay 2 hours post randomization

Platelet reactivity

Platelet reactivity assessed by VerifyNow P2Y12 assay 5 days post randomization

Hyporesponsiveness rate

Hyporesponsiveness rate (PRU≥235 assessed with the VerifyNow P2Y12 assay)2 hours post randomization

Hyporesponsiveness rate

Hyporesponsiveness rate (PRU≥235 assessed with the VerifyNow P2Y12 assay)24 hours post randomization

Hyporesponsiveness rate

Hyporesponsiveness rate (PRU≥235 assessed with the VerifyNow P2Y12 assay)5 Days post randomization

Full Information

NCT ID

NCT01338909

First Posted

April 15, 2011

Last Updated

September 29, 2011

Sponsor

University of Patras

1. Study Identification

Unique Protocol Identification Number

NCT01338909

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2011

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

September 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Patras

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction

Keywords

prasugrel, clopidogrel, primary percutaneous coronary intervention, high platelet reactivity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Prasugrel

Arm Type

Experimental

Arm Description

Prasugrel 60mg immediate loading dose (Day 0)followed by 10mg/day starting from Day 1 until Day 5

Arm Title

Clopidogrel

Arm Type

Active Comparator

Arm Description

Clopidogrel 150mg/day starting from Day 1 until Day 5

Intervention Type

Drug

Intervention Name(s)

Prasugrel

Intervention Description

Prasugrel 60mg immediate loading dose (Day 0)followed by 10mg/day starting from Day 1 until Day 5

Intervention Type

Drug

Intervention Name(s)

Clopidogrel

Intervention Description

Clopidogrel 150mg/d starting from Day 1

Primary Outcome Measure Information:

Title

Platelet reactivity

Description

Platelet Reactivity assessed by VerifyNow P2Y12 assay 24 hours post randomization

Time Frame

24 hours post randomization (Day 1)

Secondary Outcome Measure Information:

Title

Platelet reactivity

Description

Platelet Reactivity assessed by VerifyNow P2Y12 assay 2 hours post randomization

Time Frame

2 hours post randomization (Day 0)

Title

Platelet reactivity

Description

Platelet reactivity assessed by VerifyNow P2Y12 assay 5 days post randomization

Time Frame

5 days post randomization (Day 5)

Title

Hyporesponsiveness rate

Description

Hyporesponsiveness rate (PRU≥235 assessed with the VerifyNow P2Y12 assay)2 hours post randomization

Time Frame

2 hours post randomization (Day 0)

Title

Hyporesponsiveness rate

Description

Hyporesponsiveness rate (PRU≥235 assessed with the VerifyNow P2Y12 assay)24 hours post randomization

Time Frame

24 hours post randomization (Day 1)

Title

Hyporesponsiveness rate

Description

Hyporesponsiveness rate (PRU≥235 assessed with the VerifyNow P2Y12 assay)5 Days post randomization

Time Frame

5 days post randomization (Day 5)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Patras University Hospital

City

Patras

ZIP/Postal Code

26500

Country

Greece

12. IPD Sharing Statement

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

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