A Phase 2, Double-Blind, Double-Dummy, Randomized, Parallel Group Dose Finding Study to Investigate the Safety and Tolerability of YM150 in Subjects with Non-Valvular Atrial Fibrillation and to Compare the Safety and Tolerability with Warfarin - OPAL-2
- Conditions
- the prevention of stroke in patients with non-valvular atrial fibrillation (NVAF)MedDRA version: 9.1Level: LLTClassification code 10049165Term: Cerebrovascular accident prophylaxis
- Registration Number
- EUCTR2007-001150-87-DE
- Lead Sponsor
- Astellas Pharma Europe B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1280
Subject is eligible for the study if all of the following apply:
1.Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written Informed Consent prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
2.Male or female subject 18 years of age (legal minimum age required per country) or older at time of informed consent.
3.Subject has paroxysmal NVAF (had 2 or more episodes of AF which terminated spontaneously documented by ECG or rhythm strip and clinical history before study screening visit), persistent NVAF (AF of more than 7 days documented by either ECG, rhythm strip or a 24-hour Holter monitor before study screening visit), or permanent NVAF (long-standing AF present at study screening visit in which previous cardioversion has failed or has been foregone).
4.Subject has prothrombin time international normalized ratio (INR) of 2.0 or below at the baseline visit.
5.Subject has CHADS2 stroke risk stratification score of 1 to 6 (see Appendix 3) at screening visit.
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
Subject will be excluded from participation if any of the following apply:
1.Female subject of childbearing potential who refuses to use a medically acceptable form of contraception throughout the study. Acceptable methods of contraception include the following: oral or injectable hormonal contraceptives, intrauterine devices, vaginal hormonal rings, and only in combination with a male condom a vaginal diaphragm or cervical caps. Male study subjects should be advised to use male condom in addition to having their partner use another acceptable method during the study and for three months after the last dose.
2.Female subject who is pregnant or lactating or has a positive pregnancy test within 72 hours prior to randomization.
3.Subject has current or recent (within 12 months prior to screening) history of stroke and/or systemic embolism (including TIA).
4.Subject has active bleeding or any condition associated with increased risk of bleeding.
5.Subject has NVAF secondary to other reversible disorders (e.g. thyrotoxicosis).
6.Subject has an indication for warfarin other than AF (including planned cardioversion).
7.Subject has had a diagnosis of Acute Coronary Syndrome (ACS), coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within previous 3 months of screening.
8.Subject has a diagnosis of left ventricular aneurysm or atrial myxoma.
9.Subject requires use of prohibited previous and concomitant medication. (i.e., thrombolytics [such as tissue Plasminogen Activator (tPA), streptokinase], antiplatelet agents [such as cilostazol, clopidogrel, ticlopidine, dipyridamole], anticoagulants [such as vitamin K antagonists, heparin, unfractionated or low molecular weight heparin, fondaparinux, thrombin inhibitors] and chronic use of nonsteroidal anti-inflammatory drugs [NSAIDs] or acetylsalicylic acid use of >100 mg/day). (see Section 5.1.3 and Appendix 1 for details)
10.Subject has a renal creatinine clearance of <60 mL/min as calculated by the Cockcroft-Gault equation at screening (see Appendix 4).
11.Subject has hepatic insufficiency or presents with AST or ALT > 2 times the upper limit of normal (ULN) or total bilirubin > 1.5 times the ULN at screening.
12.Subject has active infective endocarditis.
13.Subject has persistent blood pressure of 160 mmHg systolic or higher and/or 100 mmHg diastolic or higher at baseline with or without medication.
14.Subject has hemoglobin <10 g/dL or platelet count <100,000/µL at screening.
15.Subject has any contraindications to warfarin.
16.Subject is planned for invasive procedures with potential for bleeding.
17.Subject has any concurrent illness which, in the opinion of the Investigator, may interfere with treatment or evaluation of safety or completion of this study.
18.Subject has participated in another clinical trial of an investigational drug (including placebo) or device within 30 days (or the limit set by national law, whichever is longer) of signing informed consent for the present study.
19.Subject has participated in any YM150 clinical trials.
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