E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Stroke prevention in patients with atrial fibrillation |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003658 |
E.1.2 | Term | Atrial fibrillation |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To establish the long term safety of dabigatran etexilate and to assess the efficacy of a knowledge translation intervention on the prognosis, cardiovascular risk profile and quality of care in patients with atrial fibrillation (AF). |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Randomization to dabigatran in RE-LY and not permanently discontinued from dabigatran at the time of RE-LY termination visit 2. Patient must require long-term treatment with oral anticoagulation and investigator determines it is clinically appropriate for patient to continue receiving oral anticoagulation. 3. Written, informed consent |
|
E.4 | Principal exclusion criteria |
1. Need for anticoagulant treatment for disorders other than atrial fibrillation 2. Plan to perform a pulmonary vein ablation or surgery for cure of AF 3. Patients with prosthetic heart valves requiring anticoagulation differing from an INR of 2.03.0 4. Symptomatic or endoscopically documented gastroduodenal ulcer disease in the 30 days prior to the start of this trial 5. Severe renal impairment (estimated creatinine clearance <=30 mL/min) based upon last results available from RE-LY 1160.26 (should be from within the past year) 6. Anaemia (haemoglobin <100g/L) or thrombocytopenia (platelet count <100 x 109/L) based upon last results available from RE-LY 1160.26 (should be from within the past year). 7. Uncontrolled hypertension (SBP >180 mmHg and/or DBP >100 mmHg) 8. Active liver disease, including known hepatitis A, B or C 9. Active infective endocarditis 10. Women who are pregnant, lactating or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study 11. Patients who have received an investigational drug other than dabigatran in the past 30 days or are participating in another drug study. 12. Patients considered unreliable by the investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration (i.e., demonstrated study drug compliance of less than 80% in RE-LY or was noncompliant with study visits in RE-LY), or has any condition which in the opinion of the investigator would not allow safe participation in the study (e.g., drug addiction, alcohol abuse). 13. Current use of quinidine |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1. Since the objective of this trial is safety, there are no primary efficacy endpoints. Safety will primarily be determined by the occurrence of major bleeding. 2. The primary endpoint for knowledge translation is the composite endpoint of vascular death, stroke, myocardial infarction (MI), non-CNS systemic embolism, major bleeding and hospitalization for heart failure. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 300 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 7 |