Clinical study to compare two different doses of prasugrel given before the cardiac operation.
- Conditions
- Acute coronary syndromeMedDRA version: 14.1Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disordersMedDRA version: 14.1Level: LLTClassification code 10071111Term: Non ST segment elevation acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2009-014176-22-LT
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 4100
[1] Present with acute coronary syndromes (ACS) consisting of non-STsegment elevation (NSTEMI) with elevated troponin. NSTEMI is defined as a history of chest discomfort or ischemic symptoms of =10 minutes duration at rest =48 hours prior to entry into the study with no evidence of persistent ST-segment elevation. Elevated troponin is defined as a troponin T or I =1.5 times the upper limit of normal (ULN).
[2] Are scheduled for coronary angiography/PCI =2 and <24 hours from the time of planned randomization. If necessary due to timing constraints,
coronary angiography/PCI may be scheduled the next day with the intention to perform coronary angiography/PCI within 24 hours, but
definitely no later than 48 hours from randomization.
[3] Must be eligible for treatment with prasugrel, ASA, and a GPIIb/IIIa
inhibitor as per respective labels.
[4] May be on a maintenance dose of clopidogrel 75 mg and must be able to switch to prasugrel.
[5] Must be enrolled at a cardiac catheterization laboratory hospital or at a
hospital/ambulance service affiliated with a cardiac catheterization laboratory hospital.
[6] Must be of a legal age (and at least 18 years of age) and of competent
mental condition to provide written informed consent before entering the
study. Informed consent must be signed by the study participant or
authorized representative, if allowed by local rules and regulations.
[7] Must not be of child-bearing potential (1 year post-menopausal or
surgically sterile).
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 2050
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2050
Cardiovascular Exclusion Criteria:
[1] Present with ST-segment elevation myocardial infarction (STEMI) at the time of entry or randomization into the study defined as follows:
ST-segment elevation myocardial infarction is defined as a history of
chest discomfort or ischemic symptoms of >20 minutes duration at rest =14 days prior to entry into the study with one of the following present on at least one ECG prior to randomization:
a) ST-segment elevation =1 mm in two or more contiguous ECG
leads.
b) New or presumably new left bundle branch block (LBBB).
c) ST-segment depression =1 mm in two anterior precordial leads
(V1 through V4) with clinical history and evidence suggestive of
true posterior infarction.
[2] Have cardiogenic shock (systolic blood pressure <90 mm Hg associated
with clinical evidence of end-organ hypoperfusion, or subjects requiring
vasopressors to maintain systolic blood pressure over 90 mm Hg and
associated with clinical evidence of end-organ hypoperfusion).
[3] Have refractory ventricular arrhythmias.
[4] Have New York Heart Association (NYHA) Class IV congestive heart failure (CHF); see Attachment TADF.3 for NYHA CHF classifications.
[5] Have had cardiac arrest within 1 week of entry or randomization into the study.
Bleeding Risk Exclusion Criteria
[6] Have any of the following:
(a) Prior history of hemorrhagic or ischemic stroke, a transient
ischemic attack (TIA), or sub-arachnoid hemorrhage.
(b) History of intracranial neoplasm, arteriovenous malformation, or
aneurysm.
[7] Have received fibrinolytic therapy within 48 hours of entry or
randomization into the study.
[8] Have active pathological bleeding or history of bleeding diathesis.
[9] Have clinical findings, in the judgment of the investigator, associated with an increased risk of bleeding.
[10] Have known anemia.
[11] Have had recent surgery (within 4 weeks of entry into the study) or are scheduled to undergo surgery within the next 2 months.
Prior/Concomitant Therapy Exclusion Criteria:
[12] Have received a loading dose of a thienopyridine (ticlopidine,
clopidogrel or prasugrel) or a maintenance dose of prasugrel or
ticlopidine within 7 days of entry into the study.
[13] Are receiving a GPIIb/IIIa inhibitor (eptifibatide, tirofiban, or abciximab).
[14] Are receiving warfarin or other coumarin derivatives.
[15] Are receiving or will receive oral anticoagulation or other oral
antiplatelet therapy (except aspirin [ASA]) that cannot be safely
discontinued within the next 3 months.
[16] Are receiving daily treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclooxygenase-2 (COX2) inhibitors that cannot be discontinued or are anticipated to require >2 weeks of daily treatment with NSAID or COX2 inhibitors during the study.
General Exclusion Criteria:
[17] Are investigator site personnel directly affiliated with the study or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
[18] Are employed by Eli Lilly & Company, Ube Industries Limited, or
Daiichi Sankyo Company Limited (that is, employees, temporary
contract workers, or designees responsible for the conduct of the study) Immediate family of Lilly employees may participate in Lilly-sponsored clinical studies but are not permitted to participate at a Lilly facility. Immediate family is defined as a spouse, paren
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method