A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects With a Recent Acute Coronary Syndrome - ATLAS ACS 2 TIMI 51

Conditions: Acute Coronary Syndrome (ACS)
MedDRA version: 9.1Level: LLTClassification code 10051592Term: Acute coronary syndrome

Registration Number: EUCTR2008-002708-25-IT

Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 16000

Inclusion Criteria

Man or woman 18 years of age or older
Currently receiving ASA therapy (75 to 100 mg/day) alone or in combination with a thienopyridine (clopidogrel or ticlopidine per national dosing recommendation)
Have been hospitalized for symptoms suggestive of ACS that lasted at least 10 minutes at rest, and occurred 48 hours or less before hospital presentation and have a diagnosis of:
?STEMI:
elevation of ST-segment more than 0.1 millivolt (mV) in 2 or more continuous ECG leads, or new left bundle branch block, or ST segment depression 0.1 mV or greater in 2 of the precordial leads V1 V4 with evidence suggestive of true posterior infarction, all with elevated biomarkers of myocardial necrosis (creatinine kinase muscle and brain isoenzyme [CK-MB] or troponin)
?NSTEMI:
Transient ST-segment elevation, or ST-segment depression, or T-wave changes consistent with myocardial ischemia along with elevated biomarkers of myocardial necrosis (creatinine kinase-muscle and brain isoenzyme [CK-MB] or troponin)
?UA with at least 1 of the following:
?transient or persistent ST-segment deviation 0.1 mV or greater in 1 or more ECG leads
?TIMI risk score of 3.
Subjects who are 18 to 54 years of age inclusive must also have either diabetes mellitus or a prior MI in addition to the presenting ACS event.
Women must be:
? postmenopausal (for at least 2 years), or
?surgically sterile, (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or
?abstinent (at the discretion of the investigator/per local regulations), or
?if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method, male partner sterilization) as local regulations permit, before entry, and must agree to continue to use the same method of contraception throughout the study.
Women of childbearing potential must have a negative urine  human chorionic gonadotropin ( hCG) pregnancy test at screening. Serum pregnancy testing may be performed if required by local regulation.
Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
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

Exclusion Criteria

Bleeding Risk
Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding, such as, but not limited to, the following:
?active internal bleeding, clinically significant bleeding, bleeding at a noncompressible site, or bleeding diathesis within 30 days of randomization
?platelet count <90,000/L at screening
?history of intracranial hemorrhage
?major surgery, biopsy of a parenchymal organ, or serious trauma (including head trauma) within 30 days before randomization
?clinically significant gastrointestinal bleeding within 12 months before randomization
?have an International Normalized Ratio (INR) known to be >1.5 at the time of screening
?abciximab bolus or infusion within the past 8 hours, or an eptifibatide or tirofiban bolus or infusion within the past 2 hours before randomization
?any other condition known to increase the risk of bleeding
Severe concomitant diseases such as:
Cardiogenic shock at the time of randomization
Ventricular arrhythmias refractory to treatment at the time of randomization
Calculated creatinine clearance <30 mL/min at screening
Known significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis), or liver function test (LFT) abnormalities (confirmed with repeat testing) which would require study drug discontinuation, i.e., ALT >5 times the ULN or ALT >3 times the ULN plus total bilirubin >2 times the ULN
A prior stroke in a subject currently receiving ASA plus a thienopyridine (Note: Subjects with a prior stroke receiving ASA therapy alone are eligible for inclusion in the study.)
Anemia (i.e., hemoglobin <10 g/dL) at screening
Known clinical history of HIV infection at screening
Substance abuse (drug or alcohol) problem within the previous 6 months
Any severe condition that would limit life expectancy to less than 6 months
General:
Systemic treatment with strong CYP 3A4 and P-gp inhibitors (e.g., certain azoleantimycotics, such as ketoconazole and HIV protease inhibitors, such as ritonavir). These active substances are strong inhibitors of both CYP3A4 and P gp.
Allergy or hypersensitivity to any component of rivaroxaban or placebo excipients (includes lactose, microcrystalline cellulose, magnesium stearate, hypromellose, macrogol, croscarmellose sodium, sodium lauryl sulfate, titanium oxide)
Known aspirin allergy
Atrial fibrillation or other condition requiring anticoagulation (e.g., warfarin sodium)
Use of disallowed therapies (see Section 8, Prestudy and Concomitant Therapy)
Received an investigational drug or used an investigational medical device within 30 days before the planned start of treatment, or are currently enrolled in an investigational study
Anticipated need for chronic (more than 4 weeks) therapy with non steroidal anti-inflammatory drugs (NSAIDs)
Is pregnant or breast-feeding or planning to become pregnant during the study
Have previously completed or withdrawn from this study
Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements
Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator