Acute Coronary Syndrome MedDRA version: 8.1 Level: LLT Classification code 10051592 Term: Acute coronary syndrome
Conditions
Interventions
Product Name: Rivaroxaban (BAY 59-7939)(JNJ-39039039)
Product Code: BAY 59-7939 (JNJ-39039039)
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Rivaroxaban
CAS Number: 366789-02-8
Current
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must satisfy the following criteria to be enrolled in the study: - man or woman between 18 and 75 years of age, inclusive, for Stage 1. Subjects older than 75 years of age will be allowed to enroll in the 20-mg or lower total daily dose panels during Stage 1 assuming an acceptable safety profile is demonstrated, as determined by The Operations Committee in consultation with the IDMC Chair. For Stage 2, subjects over 75 years of age will be allowed to enroll assuming an acceptable safety profile is demonstrated in Stage 1. - female subjects must be surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study; female subjects of childbearing potential must have a negative urine ß-hCG pregnancy test at screening. - subjects must have signed an informed consent document. - in countries where health authorities have approved the pharmacogenomic testing, subjects must have signed an informed consent for genetic testing indicating that they agree to participate in the genetic part of the study; participation in the genetic testing component is not mandatory for participation in the study. - have symptoms suggestive of ACS that lasted at least 10 minutes at rest occurring within 7 days of randomization - have either a diagnosis of STEMI or a diagnosis of NSTEMI or UA with at least 1 of the follow: - elevated cardiac enzyme marker (e.g., CK-MB or troponin I or T) - =1 mm ST-segment deviation (i.e., elevation or depression) - TIMI risk score =3 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
Exclusion criteria: Conditions that may increase the risk of bleeding: - active internal bleeding, clinically significant bleeding, bleeding at a noncompressible site, or bleeding diathesis within 30 days of randomization - platelet count 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 Conditions that may increase the risk of intracranial hemorrhage: - history of hemorrhagic stroke at any time or clinical presentation consistent with intracranial hemorrhage (e.g., severe headache or new neurologic deficit after fibrinolytic therapy) - recent ischemic stroke or transient ischemic attack (TIA) of any etiology within 30 days of randomization - recent head trauma. (i.e., within 30 days of randomization) - known intracranial neoplasm, arteriovenous malformation, or aneurysm - sustained uncontrolled hypertension: systolic blood pressure of =180 mmHg or diastolic pressure of =100 mmHg that persists for more than 1 hour at time of screening despite treatment Required drugs or procedures: - the need for continued treatment with anticoagulant drugs (e.g., warfarin) - systemic treatment with a strong inhibitor of cytochrome P450 3A4, such as ketoconazole or protease inhibitors, within 4 days before randomization or planned treatment during the time period of the study - treatment with a strong inducer of cytochrome P450 3A4, such as rifampin/rifampicin within 4 days before randomization or planned treatment during time period of the study - planned PCI or peripheral arterial intervention Severe concomitant diseases such as: - cardiogenic shock - refractory ventricular arrhythmias - calculated creatinine clearance 3 times the ULN - anemia (i.e., hemoglobin <10 g/dL) at the screening visit - have received transfusion of red blood cells (RBCs), whole blood, or platelets within 7 days before randomization - known human immunodeficiency virus (HIV) infection at the screening visit - substance abuse (drug or alcohol) problem within the previous 3 years - have any severe condition that would limit life expectancy to less than 6 months General: - known allergy to aspirin - known 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) - have received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment - is pregnant or breast-feeding or planning to become pregnant during the study - have previously completed or withdrawn from this study or any other study of rivaroxaban - 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 famil
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Stage 1 Dose Escalation The primary objective of Stage 1 (Dose Escalation) of this study is to evaluate the safety of rivaroxaban in subjects with recent acute coronary syndrome (ACS) (including ST-segment elevation myocardial infarction [STEMI], nonST segment elevation myocardial infarction [NSTEMI], and unstable angina [UA]) who are treated with aspirin alone or aspirin plus a thienopyridine. Stage 2: Dose Confirmation The primary objective of Stage 2 (Dose Confirmation) of this study is to evaluate the ability of rivaroxaban to reduce the combined incidence of death, myocardial infarction (MI) or repeat myocardial infarction (reMI), stroke (ischemic, hemorrhagic or unknown), or severe recurrent ischemia requiring revascularization in subjects with recent ACS (including STEMI, NSTEMI, or UA) who are treated with aspirin alone or aspirin plus a thienopyridine after medical therapy or percutaneous coronary intervention (PCI) as acute treatment.;Secondary Objective: Stage 1: Dose Escalation Evaluation of: 1) primary and secondary efficacy endpoints to enable a benefit:risk assessment; 2) the pk/pd of rivaroxaban; 3) the ability to reduce thrombin generation; 4) the overall safety of treatment. Stage 2: Dose Confirmation Evaluate the ability of rivaroxaban to 1) reduce the composite of death, MI, or stroke through 6 months of treatment; 2) reduce the composite of death, MI, stroke, or severe recurrent ischemia through 6 months; 3) reduce each component of the primary efficacy endpoint; 4) reduce ischemia as measured by continuous ST segment monitoring; 5) reduce the incidence of LV thrombus at Day 10 to 14 after randomization in subjects presenting with anterior STEMI; 6) to assess the net clinical benefit by measuring the composite of death, MI, stroke, severe recurrent ischemia requiring revascularization, TIMI major bleed or TIMI minor bleed through 6 months; 7) to assess the overall safety of treatment.;Primary end point(s): Stage 1 (Dose Escala | — |
Countries
Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Netherlands, Spain, Sweden, United Kingdom
Outcome results
None listed