A Phase 2, Placebo-Controlled, Randomized, Double-Blind, Parallel Arm, Dose RangingStudy to Evaluate Safety and Efficacy of Apixaban In Patients with a Recent AcuteCoronary Syndrome. And Parmacogenetics Blood Sample Amendment 01 dated 17-Feb-2006 - APPRAISE-1
- Conditions
- ACUTE CORONARY SYNDROMES,NOS
- Registration Number
- EUCTR2005-004338-42-GB
- Lead Sponsor
- Bristol Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1900
1) Signed written informed consent;
2) Recent (=7 days) Acute Coronary Syndrome with:
a) symptoms of myocardial ischemia (chest pain, dyspnea, etc.) lasting a total of at
least 10 minutes
And either
b) elevation in cardiac biomarkers (troponin T or I or creatine kinase-MB) above the
upper limit of normal
or
c) dynamic ST segment deviation [depression or elevation of =0.1 mV (1.0 mm)]
3) Clinically stable, receiving standard care for ACS, including antiplatelet therapy
[acetylsalicylic acid (ASA) = 165 mg/day, with or without clopidogrel 75 mg/day,
based on the choice of the treating physician]
4) Either unknown coronary anatomy or >50% stenosis in at least one major epicardial coronary artery;
5) Women who are not of childbearing potential (i.e., who are postmenopausal or
surgically sterile), and men, ages 18 (or legal age of consent) to 90.
Plus 1 or more additional risk characteristics from the following:
1) Age = 65 years
2) Both elevation in cardiac markers and dynamic ST deviation = 1 mm
3) Diabetes mellitus
4) MI within the last 12 months (other than qualifying event)
5) Cerebrovascular disease [prior (>3 months) ischemic stroke; prior TIA or
asymptomatic >70% stenosis in either internal carotid artery]
6) Peripheral vascular disease (claudication with decreased pulses, a prior peripheral
revascularization procedure, or an ABI <0.9)
7) Prior symptomatic CHF or a left ventricular ejection fraction <40%
8) Non-revascularized multivessel CAD (=2 vessels)
9) Mild or moderate renal insufficiency (calculated CrCl 30-90 mL/min)
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1) Women of child bearing potential:
a. Any female who has experienced menarche and who has not undergone successful surgical sterilization or is not postmenopausal.
b. Women who are pregnant or breastfeeding.
c. Women with a positive pregnancy test on enrollment or prior to study drug
administration.
2) Scheduled/planned cardiac catheterization, PCI, CABG or other invasive procedure
planned in the 26 weeks following randomization;
3) Persistent severe hypertension, defined as systolic blood pressure of =180 mm Hg or diastolic pressure of =110 mm Hg
4) Severe renal dysfunction (calculated creatinine clearance <30 mL/min)
5) Active bleeding or at high risk for bleeding (e.g., cirrhosis of the liver, any history of
intracranial hemorrhage)
6) Known coagulopathy
7) Acute pericarditis or pericardial effusion
8) Recent stroke (within the last 3 months)
9) Prior New York Heart Association (NYHA) Class IV;
10) Platelet count =100,000/mm3
11) Hemoglobin < 10 g/dL;
12) Hematocrit < 30%;
13) Inability to take aspirin due to allergy or intolerance;
14) Need for ongoing treatment with a parenteral or oral anticoagulant (see Section
6.4.1), eg, subjects with mechanical valves, warfarin eligible atrial fibrillation
15) Need for chronic (>3 months) daily NSAID or chronic high dose ASA use (>325
mg/day);
16) Below the legal lower age (country specific);
17) Participation in another investigational drug or device study within the prior 30 days;
18) Subjects who participated previously in this or any other study involving
BMS-562247;
19) Any condition which, in the opinion of the Investigator, may pose a significant hazard to the subject if he or she is enrolled in the trial;
20) Subject inability to follow the protocol;
21) Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
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