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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014176-22-NL

Enrollment

4100

Registered

2009-08-31

Start date

2010-03-10

Completion date

Unknown

Last updated

2013-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndromes MedDRA version: 14.1 Level: PT Classification code 10051592 Term: Acute coronary syndrome System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: Efient Product Name: prasugrel Pharmaceutical Form: Film-coated tablet INN or Proposed INN: prasugrel CAS Number: 389574-19-0 Current Sponsor code: LY640315 Concentration unit: mg milligra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: NSTEMI with elevated troponin Scheduled for early coronary angiography and PCI Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: STEMI Cardiogenic shock at time of randomisation refractory ventricular arrhythmias congestive heart failure cardiac arrest prior TIA or stroke active pathological bleeding severe hepatic impairment

Design outcomes

Primary

Measure	Time frame
Main Objective: Reduction in cardiovascular events NSTEMI patients undergoing PCI;Secondary Objective: Safety and net clinical benefit;Primary end point(s): Composite efficacy endpoint of cardiovascular events;Timepoint(s) of evaluation of this end point: 7 days from randomisation	—

Secondary

Measure	Time frame
Secondary end point(s): Additional secondary efficacy objectives will compare the 2 prasugrel LD regimens in terms of the incidence of the following: • CV death, MI, or stroke through 30 days from randomization • CV death or MI through 30 days from randomization • CV death, MI, or UR through 30 days from randomization • CV death through 30 days from randomization • Definite or probable stent thrombosis according to the Academic Research Consortium criteria through 30 days from randomization • Net clinical benefit (composite of all-cause death, MI, stroke, or all TIMI major bleeding) through 30 days from randomization And in addition, • Rise in troponin from baseline (obtained at Visit 1) to pre-PCI (obtained at Visit 3);Timepoint(s) of evaluation of this end point: 30 days from randomisation	—

Measure

Time frame

Secondary end point(s): Additional secondary efficacy objectives will compare the 2 prasugrel LD regimens in terms of the incidence of the following: • CV death, MI, or stroke through 30 days from randomization • CV death or MI through 30 days from randomization • CV death, MI, or UR through 30 days from randomization • CV death through 30 days from randomization • Definite or probable stent thrombosis according to the Academic Research Consortium criteria through 30 days from randomization • Net clinical benefit (composite of all-cause death, MI, stroke, or all TIMI major bleeding) through 30 days from randomization And in addition, • Rise in troponin from baseline (obtained at Visit 1) to pre-PCI (obtained at Visit 3);Timepoint(s) of evaluation of this end point: 30 days from randomisation

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Countries

Austria, Belgium, Canada, Denmark, Finland, France, Germany, Hungary, Israel, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Sweden, Turkey

Contacts

Public ContactClinical Trial Information

Eli Lilly & Company

EU_Lilly_Clinical_Trials@lilly.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026