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

This study has been completed.
Sponsor:
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01015287
First received: November 17, 2009
Last updated: January 17, 2014
Last verified: January 2014

November 17, 2009
January 17, 2014
December 2009
January 2013   (final data collection date for primary outcome measure)
The Percentage of Participants With Occurrence of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Urgent Revascularization (UR), or Glycoprotein (GP) IIb/IIIa Inhibitor Bailout [ Time Frame: First loading dose (LD) through 7 days after first LD ] [ Designated as safety issue: No ]
The percentage of participants is the total number of participants experiencing a CV death, MI, stroke, UR or GPIIb/IIIa Inhibitor bailout divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
The time to occurrence of Cardiovascular Death, MI, Stroke, Urgent Revascularization, or GP IIb/IIIa Inhibitor bailout [ Time Frame: 7 days after randomization ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01015287 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With All-Cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding [ Time Frame: First loading dose (LD) through 7 days after first LD ] [ Designated as safety issue: Yes ]
    The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
  • Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke Through 30 Days From First Loading Dose (LD) [ Time Frame: First LD through 30 days after first LD ] [ Designated as safety issue: Yes ]
    The percentage of participants is the total number of participants experiencing a CV death, MI, or stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
  • Percentage of Participants With Incidence of Cardiovascular (CV) Death or Myocardial Infarction (MI) Through 30 Days From First Loading Dose (LD) [ Time Frame: First LD through 30 days after first LD ] [ Designated as safety issue: Yes ]
    The percentage of participants is the total number of participants experiencing a CV death or MI divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
  • Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Urgent Revascularization (UR) Through 30 Days From First Loading Dose (LD) [ Time Frame: First LD through 30 days after first LD ] [ Designated as safety issue: Yes ]
    The percentage of participants is the total number of participants experiencing a CV death, MI, or UR divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
  • Percentage of Participants With Incidence of Cardiovascular (CV) Death Through 30 Days From First Loading Dose (LD) [ Time Frame: First LD through 30 days after first LD ] [ Designated as safety issue: Yes ]
    The percentage of participants is the total number of participants experiencing a CV death divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
  • Percentage of Participants With Incidence of Definite or Probable Stent Thrombosis (ST) According to the Academic Research Consortium (ARC) Criteria Through 30 Days From First Loading Dose (LD) [ Time Frame: First LD through 30 days after first LD ] [ Designated as safety issue: Yes ]
    ARC criteria were used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least one of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause. The percentage of participants is the total number of participants experiencing a definite or probable stent thrombosis divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
  • Percentage of Participants With All-cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding Through 30 Days From First Loading Dose (LD) [ Time Frame: First LD through 30 days after first LD ] [ Designated as safety issue: Yes ]
    The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
  • Change in Standardized Troponin From Baseline to Percutaneous Coronary Intervention (PCI) [ Time Frame: Baseline, before PCI (not greater than 48 hours after randomization) ] [ Designated as safety issue: Yes ]
    Standardized troponin is defined as the ratio of the assayed troponin value divided by the upper limit of normal (ULN). Least Squares (LS) means were obtained from an Analysis of Covariance (ANCOVA) model with treatment as a fixed effect and baseline standardized troponin as a covariate.
  • Percentage of Participants With Incidence of All Coronary Artery Bypass Graft (CABG) or Non-CABG Thrombolysis In Myocardial Infarction (TIMI) Major Bleeding [ Time Frame: First loading dose (LD) through 7 days after first LD ] [ Designated as safety issue: Yes ]
    The percentage of participants is the total number of participants experiencing a CABG or non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.
  • Net clinical benefit of all-cause death, Myocardial Infarction (MI), stroke, or all Coronary Artery Bypass Graft (CABG) and non-CABG Thrombolysis in Myocardial Infarction (TIMI) major bleeding [ Time Frame: 7 days after randomization ] [ Designated as safety issue: Yes ]
  • Incidence of Cardiovascular (CV) death, MI, or stroke through 30 days from randomization [ Time Frame: 30 days after randomization ] [ Designated as safety issue: Yes ]
  • Incidence of CV death or MI through 30 days from randomization [ Time Frame: 30 days after randomization ] [ Designated as safety issue: Yes ]
  • Incidence of CV death, MI, or Urgent Revascularization (UR) through 30 days from randomization [ Time Frame: 30 days after randomization ] [ Designated as safety issue: Yes ]
  • Incidence of CV death through 30 days from randomization [ Time Frame: 30 days after randomization ] [ Designated as safety issue: Yes ]
  • Incidence of definite or probable stent thrombosis according to the Academic Research Consortium criteria through 30 days from randomization [ Time Frame: 30 days after randomization ] [ Designated as safety issue: Yes ]
  • Net clinical benefit of all-cause death, MI, stroke or all TIMI major bleeding through 30 days from randomization [ Time Frame: 30 days after randomization ] [ Designated as safety issue: Yes ]
  • Change in Troponin from baseline to PCI [ Time Frame: Baseline to not greater than 48 hours after randomization ] [ Designated as safety issue: Yes ]
  • Incidence of all CABG or non-CABG TIMI major bleeding [ Time Frame: 7 days after randomization ] [ Designated as safety issue: Yes ]
Summary of All-Cause Death [ Time Frame: Randomization through 30 days ] [ Designated as safety issue: Yes ]
All deaths, regardless of possible relatedness, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table.
Not Provided
 
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

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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Coronary Syndromes
  • Drug: Placebo
    Administered once orally
  • Drug: Prasugrel
    Administered orally
    Other Names:
    • LY640315
    • Efient
    • Effient
    • CS-747
  • Experimental: Non pre-treatment
    A placebo oral loading dose is given at the time of diagnosis and a 60 milligrams (mg) oral loading dose of prasugrel is given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
    Interventions:
    • Drug: Placebo
    • Drug: Prasugrel
  • Experimental: Split Loading Dose
    A 30 mg oral loading dose of prasugrel is given at diagnosis and a 30 mg oral dose of prasugrel is given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days
    Intervention: Drug: Prasugrel

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4033
February 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have acute coronary syndrome consisting of non-ST-segment elevation with elevated troponin
  • Scheduled for coronary angiography/PCI greater than or equal to 2 and less than 24 hours from time of planned randomization, but no more than 48 hours from randomization
  • Must be eligible for treatment with prasugrel, aspirin (ASA), and a glycoprotein IIb/IIIa receptor (GPIIb/IIIa) inhibitor as per respective labels
  • May be on a maintenance dose of clopidogrel 75 mg and must be able to switch to prasugrel
  • Must be enrolled at a cardiac catheterization laboratory hospital or at a hospital/ambulance service affiliated with a cardiac catheterization laboratory hospital

Exclusion Criteria:

  • Present with ST-segment elevation myocardial infarction (STEMI) at the time of entry or randomization
  • Have cardiogenic shock
  • Have refractory ventricular arrhythmias
  • Have New York Heart Association (NYHA) Class IV congestive heart failure (CHF)
  • Have had cardiac arrest within 1 week of entry or randomization into the study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Canada,   Czech Republic,   Finland,   France,   Germany,   Hungary,   Israel,   Italy,   Latvia,   Lithuania,   Netherlands,   Poland,   Portugal,   Romania,   Slovakia,   Sweden,   Turkey
 
NCT01015287
12918, H7T-MC-TADF
Yes
Eli Lilly and Company
Eli Lilly and Company
Daiichi Sankyo Co., Ltd.
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP