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

Phase 3

Completed

Conditions: Acute Coronary Syndrome
Heart Infarction
10011082

Registration Number: NL-OMON33722

Lead Sponsor: Janssen-Cilag

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 225

Inclusion Criteria

Potential subjects must satisfy the following criteria to be enrolled in the study:
* 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 *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.

Exclusion Criteria

- conditions that may increase the risk of bleeding
- severe concomitant diseases
- required drugs which are not allowed acc. to the protocol (eg. need for continued treatment with anticoagulant drugs, treatment with strong CYP 3A4 and P-gp inhibitors)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of the study is to determine whether rivaroxaban in<br /><br>addition to standard care reduces the risk of the composite of cardiovascular<br /><br>(CV) death, myocardial infarction (MI), or stroke in subjects with a recent ACS<br /><br>compared with placebo in addition to standard care.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Evaluation of secundary efficacy endpoints (composites of all cause death,<br /><br>MI, stroke, recurrent ischemia requiring revascularisation and/or<br /><br>hospitalisation)<br /><br>* To examine the effect of rivaroxaban on net clinical outcome, defined as the<br /><br>composite of CV death, MI, ischemic stroke, or a Thrombolysis in Myocardial<br /><br>Infarction (TIMI) major bleeding event not associated with coronary artery<br /><br>bypass graft (CABG) surgery<br /><br>* Evaluation of safety of rivaroxaban (bleeding risk)<br /><br>* Evaluation of (patient completed) health questionnaires as well as evaluation<br /><br>of medical resource utilization.<br /><br><br /><br></p><br>