NCT01015287

A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction

A Comparison of Prasugrel at the Time of Percutaneous Coronary Intervention (PCI) Or as Pretreatment At the Time of Diagnosis in Patients With Non-ST-Elevation Myocardial Infarction (NSTEMI): The ACCOAST Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,033 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to investigate the potential benefits/risks regarding pretreatment with prasugrel in non-ST-elevation myocardial infarction (NSTEMI) participants with elevated troponin scheduled for coronary angiography/percutaneous coronary intervention (PCI).

Detailed description

This trial consists of two arms. One arm is a non pre-treatment arm. Participants in this arm will receive placebo immediately after NSTEMI diagnosis and prior to the diagnostic coronary angiography. A 60 mg prasugrel loading dose will be given immediately after coronary angiography when proceeding to PCI. Subsequently, participants will receive daily maintenance doses of prasugrel until day 30. Participants who are greater than or equal to 75 years of age or who have a body weight less than 60 kilograms (kg) will receive 5 mg oral dose daily. All others will receive a 10 mg oral daily maintenance dose for 30 days. The other arm is a pre-treatment arm where participants will receive a split loading dose regimen with 30 mg of prasugrel administered immediately after NSTEMI diagnosis and prior to diagnostic coronary angiography. The remainder of the loading dose (30 mg) will be administered when the participants are proceeding to PCI. Subsequently, participants will receive daily maintenance doses of prasugrel until day 30. Participants who are greater than or equal to 75 years of age or who have a body weight less than 60 kg will receive 5 mg oral dose daily. All others will receive a 10 mg oral daily maintenance dose for 30 days.

Conditions

• Acute Coronary Syndromes

Interventions

Type	Name	Description
DRUG	Placebo	Administered once orally
DRUG	Prasugrel	Administered orally

Timeline

• Start date: 2009-12-01
• Primary completion: 2013-01-01
• Completion: 2013-02-01
• First posted: 2009-11-18
• Last updated: 2014-02-28
• Results posted: 2014-02-28

Locations

153 sites across 19 countries: Austria, Belgium, Canada, Czechia, Finland, France, Germany, Hungary, Israel, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Slovakia, Sweden, Turkey (Türkiye)