High (100mg) Versus Standard (60mg) Loading Dose of Prasugrel in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)

Platelet Reactivity Clinical Trial

Official title:

High (100mg) Versus Standard (60mg) Loading Dose of Prasugrel in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01835353
• Other study ID #: PATRASCARDIOLOGY-13
• Status: Completed
• Phase: Phase 3
• First received: April 15, 2013
• Last updated: September 20, 2013
• Start date: June 2012
• Est. completion date: July 2013

Study information

• Verified date: September 2013
• 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 prospective, multi-center, non-randomized, controlled study in 2 sequential groups of P2Y12 inhibitor-naive consecutive STEMI patients undergoing primary PCI. Following aspirin 325 mg LD, patients will receive 60 mg or 100 mg of prasugrel, respectively. Platelet reactivity (PR)will be assessed at Hour 0 (before prasugrel's administration immediately prior to PCI) and at Hours 0.5, 1, 2, 4 thereafter. Platelet function testing (in PRU) will be performed with the VerifyNow (Accumetrics Inc., San Diego, CA, USA) P2Y12 function assay.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 74 Years

Eligibility

Inclusion Criteria:

• ST elevation myocardial infarction

• Pain onset <12 hours

• Age >18 and <75 years

• Written informed consent

Exclusion Criteria:

• history of stroke/transient ischemic attack

• oral anticoagulation

• hemodynamic instability

• platelet count <100000/µL

• hematocrit <30%

• creatinine clearance <30 ml/min

• severe hepatic dysfunction

• active bleeding

• weight <60 Kg

• periprocedural IIb/IIIa inhibitor administration

Study Design

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Platelet Reactivity

Intervention

Drug:
• Prasugrel 100mg loading dose

• Prasugrel 60mg loading dose
Prasugrel 60mg loading dose

Locations

Country	Name	City	State
Greece	Dimitrios Alexopoulos	Patras	Achaia

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 in Platelet reactivity units (PRU) at Hour 2	Platelet reactivity in Platelet reactivity units (PRU) 2 hours post randomization	2 hours	No
Secondary	Platelet reactivity in platelet reactivity units (PRU)at hour 1	Platelet reactivity in platelet reactivity units (PRU)1 hour post randomization	1 hour	No
Secondary	Platelet reactivity in platelet reactivity units (PRU)at hour 0.5	Platelet reactivity in platelet reactivity units (PRU)0.5 hour post randomization	0.5 hours	No
Secondary	Platelet reactivity in platelet reactivity units (PRU)at hour 4	Platelet reactivity in platelet reactivity units (PRU)4 hours post randomization	4 hours	No
Secondary	High platelet reactivity rate (208 PRU threshold) at 0.5 hour	High platelet reactivity rate (208 PRU threshold) 0.5 hour post randomization	0.5 hour	No
Secondary	High platelet reactivity rate (208 PRU threshold) at 1 hour	High platelet reactivity rate (208 PRU threshold) 1 hour post randomization	1 hour	No
Secondary	High platelet reactivity rate (208 PRU threshold) at 2 hour	High platelet reactivity rate (208 PRU threshold) 2 hours post randomization	2 hours	No
Secondary	High platelet reactivity rate (208 PRU threshold) at 4 hour	High platelet reactivity rate (208 PRU threshold) 4 hours post randomization	4 hours	No