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

NCT01338909 | Completed Phase 3

• 1 other identifier: PATRASCARDIOLOGY-4
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Platelet reactivity

  Platelet Reactivity assessed by VerifyNow P2Y12 assay 24 hours post randomization

  24 hours post randomization (Day 1)

Secondary Outcomes (5)

• Platelet reactivity

  2 hours post randomization (Day 0)

• Platelet reactivity

  5 days post randomization (Day 5)

• Hyporesponsiveness rate

  2 hours post randomization (Day 0)

• Hyporesponsiveness rate

  24 hours post randomization (Day 1)

• Hyporesponsiveness rate

  5 days post randomization (Day 5)

Study Arms (2)

Prasugrel

EXPERIMENTAL

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

Drug: Prasugrel

Clopidogrel

ACTIVE COMPARATOR

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

Drug: Clopidogrel

Interventions

Prasugrel DRUG

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

Prasugrel

Clopidogrel DRUG

Clopidogrel 150mg/d starting from Day 1

Clopidogrel

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Patras: lead

Study Sites (1)

Patras University Hospital

Pátrai, 26500, Greece

Location

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Prasugrel Hydrochloride; Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ticlopidine; Thienopyridines; Pyridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: April 20, 2011
• Study Start: April 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 30, 2011

Record last verified: 2011-09

Locations

GR (1)