Prevention of Stroke and Systemic Embolic Events in Patients With Atrial Fibrillation
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ClinicalTrials.gov Identifier: NCT00684307 |
Recruitment Status :
Completed
First Posted : May 26, 2008
Results First Posted : September 22, 2011
Last Update Posted : March 23, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Nonvalvular Atrial Fibrillation | Drug: AZD0837 Drug: Vitamin-K antagonist at INR 2-3 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1084 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Prevention |
Official Title: | A Controlled, Randomized, Parallel, Multicentre Study to Assess Safety and Tolerability of the Oral Direct Thrombin Inhibitor AZD0837, Given as an Extended-release Formulation, in the Prevention of Stroke and Systemic Embolic Events in Patients With Atrial Fibrillation |
Study Start Date : | February 2007 |
Actual Primary Completion Date : | June 2008 |
Actual Study Completion Date : | June 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
AZD0837 450 mg
|
Drug: AZD0837
ER tablet, PO, once daily for a period of 3-9 months. |
Experimental: 2
AZD0837 200 mg
|
Drug: AZD0837
ER tablet, PO, twice daily for a period of 3-9 months |
Experimental: 3
AZD0837 300 mg
|
Drug: AZD0837
ER tablet, PO, once daily for a period of 3-9 months. |
Experimental: 4
AZD0837 150 mg
|
Drug: AZD0837
ER tablet, PO, once daily for a period of 3-9 months. |
Active Comparator: 5
Vitamin-K antagonist at INR 2-3
|
Drug: Vitamin-K antagonist at INR 2-3
Tablet, PO for a period of 3-9 months.
Other Name: Warfarin |
- Bleeding Events [ Time Frame: 36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit) ]Number of patients with a bleeding event while on study drug. Patients with multiple events are counted once
- Creatinine [ Time Frame: 12 weeks according to protocol.(baseline to week 12 visit) ]Change in Creatinine values from baseline to week 12 visit for patients while on study drug (week 12 visit-baseline)
- Alanine Aminotransferase (ALAT) [ Time Frame: 36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit) ]Number of patients while on study drug with ALAT>=3 times upper limit of normal.l
- Bilirubin [ Time Frame: 36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit) ]Number of patients while on study drug with Bilirubin>=2 times upper limit of normal
- D-Dimer [ Time Frame: 14 weeks according to protocol.(enrolment to week 12 visit) ]Change in D-Dimer values from enrolment to week 12 visit for VKA naïve patients while on study drug (week 12 visit-enrolment)
- Activated Partial Thromboplastin Time (APTT) [ Time Frame: 12 weeks according to protocol.(baseline to week 12 visit) ]Change in Activated partial thromboplastin time (APTT) from baseline to week 12 visit for VKA naïve patients while on study drug (week 12 visit-baseline)
- Ecarin Clotting Time (ECT) [ Time Frame: 12 weeks according to protocol.(baseline to week 12 visit) ]Change in Ecarin clotting time (ECT) from baseline to week 12 visit for patients while on study drug (week 12 visit-baseline)
- Plasma Concentration of AZD0837 (Prodrug) [ Time Frame: 12 weeks after baseline according to protocol ]Assessment made on the week 12 visit
- Plasma Concentration of AR-H067637XX (Active Metabolite) [ Time Frame: 12 weeks after baseline according to protocol ]Assessment made on the week 12 visit
- Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype TT [ Time Frame: 36 weeks according to protocol ]Oral clearance of AR-H067637XX in subgroup of patients with genotype TT for gene polymorphism ABCB1 C3435T
- Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype TC [ Time Frame: 36 weeks according to protocol ]Oral clearance of AR-H067637XX in subgroup of patients with genotype TC for gene polymorphism ABCB1 C3435T
- Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype CC [ Time Frame: 36 weeks according to protocol ]Oral clearance of AR-H067637XX in subgroup of patients with genotype CC for gene polymorphism ABCB1 C3435T

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Nonvalvular AF (NVAF) verified by at least two ECGs in the last year separated by at least one week.
- Previous cerebral ischemic attack (stroke or TIA, >30 days prior to randomization)
- Previous systemic embolism.
- Symptomatic congestive heart failure (CHF)
- Impaired left ventricular systolic function
- Diabetes mellitus
- Hypertension requiring anti-hypertensive treatment.
Exclusion Criteria:
- AF secondary to reversible disorders, eg hyperthyroidism, drugs and pulmonary embolism
- Known contraindication to VKA treatment
- Presence of a valvular heart disease, mechanical heart valves, active endocarditis, left ventricular aneurysm or thrombus, atrial myxoma or any condition other than AF requiring chronic anticoagulation treatment
- Conditions associated with increased risk of major bleeding for example: history of intracranial bleeding, history of bleeding gastrointestinal disorder or major surgical procedure or trauma two weeks prior to randomization

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00684307
Principal Investigator: | Gregory Y Lip, Prof | University Department of Medicine, City Hospital, Birmingham, B18 7QH, England, UK |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00684307 |
Other Study ID Numbers: |
D1250C00008 |
First Posted: | May 26, 2008 Key Record Dates |
Results First Posted: | September 22, 2011 |
Last Update Posted: | March 23, 2012 |
Last Verified: | March 2012 |
Anticoagulant Treatment Risk Factors For Stroke |
Atrial Fibrillation Cardiovascular Diseases Arrhythmias, Cardiac Heart Diseases Pathologic Processes Vitamin K Warfarin Vitamins Micronutrients |
Nutrients Growth Substances Physiological Effects of Drugs Anticoagulants Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |