Stroke Prevention in Patients With Atrial Fibrillation Clinical Trial
Official title:
Long-Term Treatment With the Oral Direct Thrombin Inhibitor Ximelagatran, Compared to Warfarin, as Stroke Prophylaxis in Patients With Atrial Fibrillation. A Long Term Follow-Up Study
| Verified date | November 2010 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to evaluate tolerability of long-term treatment with ximelagatran compared to standard treatment with warfarin.
| Status | Terminated |
| Enrollment | 220 |
| Est. completion date | April 2006 |
| Est. primary completion date | June 2004 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Signed informed consent. - Completion of the study SH-TPA-0002, history of chronic atrial fibrillation (i.e. rapidly beating heart), at least one risk factor for stroke (e.g. high blood pressure, age over 65, previous stroke or similar attack, diabetes or coronary heart disease) Exclusion Criteria: - Conditions associated with increased risk of bleeding, renal impairment, known active liver disease or liver insufficiency |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Research Site | Oostduinkerke | |
| Czech Republic | Research Site | Helsingor | |
| Czech Republic | Research Site | Most | |
| Czech Republic | Research Site | Plzeo | |
| Czech Republic | Research Site | Poibram | |
| Czech Republic | Research Site | Prague | |
| Denmark | Research Site | Arhus | |
| Denmark | Research Site | Odense | |
| Finland | Research Site | Kuopio | |
| Finland | Research Site | Savonlinna | |
| Norway | Research Site | Hamar | |
| Norway | Research Site | Oslo | |
| Poland | Research Site | Plock | |
| Poland | Research Site | Siedice | |
| Poland | Research Site | Warsaw | |
| Sweden | Research Site | Lund | |
| United Kingdom | Research Site | Leicester | |
| United Kingdom | Research Site | Newcastle | |
| United States | Research Site | Palo Alto | California |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Belgium, Czech Republic, Denmark, Finland, Norway, Poland, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Adverse Events, with special regard to bleeding, thromboembolic events and discontinuation of treatment. |