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

• Sponsor: University of Patras (Other)
• Overall Status: Completed
• CT.gov ID: NCT01835353
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Arms: 2
• Duration (Months): 13
• Patients Per Site Per Month: 6.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Platelet Reactivity	Drug: Prasugrel 100mg loading dose; Drug: Prasugrel 60mg loading dose	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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)
• Study Start Date: Jun 1, 2012
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prasugrel 100mg loading dose Prasugrel 100mg loading dose	Drug: Prasugrel 100mg loading dose
Active Comparator: Prasugrel 60mg loading dose	Drug: Prasugrel 60mg loading dose; Prasugrel 60mg loading dose

Outcome Measures

Primary Outcome Measures

1. Platelet reactivity in Platelet reactivity units (PRU) at Hour 2 [2 hours]

   Platelet reactivity in Platelet reactivity units (PRU) 2 hours post randomization

Secondary Outcome Measures

1. Platelet reactivity in platelet reactivity units (PRU)at hour 1 [1 hour]

   Platelet reactivity in platelet reactivity units (PRU)1 hour post randomization

2. Platelet reactivity in platelet reactivity units (PRU)at hour 0.5 [0.5 hours]

   Platelet reactivity in platelet reactivity units (PRU)0.5 hour post randomization

3. Platelet reactivity in platelet reactivity units (PRU)at hour 4 [4 hours]

   Platelet reactivity in platelet reactivity units (PRU)4 hours post randomization

4. High platelet reactivity rate (208 PRU threshold) at 0.5 hour [0.5 hour]

   High platelet reactivity rate (208 PRU threshold) 0.5 hour post randomization

5. High platelet reactivity rate (208 PRU threshold) at 1 hour [1 hour]

   High platelet reactivity rate (208 PRU threshold) 1 hour post randomization

6. High platelet reactivity rate (208 PRU threshold) at 2 hour [2 hours]

   High platelet reactivity rate (208 PRU threshold) 2 hours post randomization

7. High platelet reactivity rate (208 PRU threshold) at 4 hour [4 hours]

   High platelet reactivity rate (208 PRU threshold) 4 hours post randomization

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 74 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dimitrios Alexopoulos	Patras	Achaia	Greece	26500

Sponsors and Collaborators

• University of Patras

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dimitrios Alexopoulos, Professor, University of Patras
• ClinicalTrials.gov Identifier: NCT01835353
• Other Study ID Numbers: PATRASCARDIOLOGY-13
• First Posted: Apr 18, 2013
• Last Update Posted: Sep 23, 2013
• Last Verified: Sep 1, 2013

• Keywords provided by Dimitrios Alexopoulos, Professor, University of Patras: prasugrel; ST elevation myocardial infarction
• Additional relevant MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction; Prasugrel Hydrochloride

Study Results

No Results Posted as of Sep 23, 2013