Phase 2
Completed N=166
A Dose Response Study of Dabigatran Etexilate(BIBR 1048) in Pharmacodynamics and Safety in Patients With Non-valvular Atrial Fibrillation in Comparison to Warfarin
Source: ClinicalTrials.gov NCT01136408 ↗Enrolled (actual)
166
Serious AEs
6.6%
Results posted
Dec 2010
Primary outcomePrimary: Frequency (Occurrence Rates) of Major Bleeding Event — 0; 1.7; 3.2 Percentage of patients
Summary
The primary objective was to evaluate the safety of dabigatran etexilate(BIBR 1048) administered orally at doses of 110 and 150 mg, twice daily, for 12 weeks in patients with non-valvular atrial fibrillation (paroxysmal, persistent or permanent) in comparison with warfarin.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency (Occurrence Rates) of Major Bleeding Event |
0; 1.7; 3.2 | — |
| PRIMARY Frequency (Occurrence Rates) of Clinically Relevant Bleeding Event |
4.3; 8.6; 8.1 | — |
| PRIMARY Frequency (Occurrence Rates) of Nuisance Bleeding Event |
19.6; 29.3; 19.4 | — |
| PRIMARY Incidence and Severity of Adverse Events |
28; 46; 35; 1; 1; 4 | — |
| PRIMARY Discontinuation of the Study Drug Due to Adverse Events |
4; 8; 4 | — |
| PRIMARY Changes in Laboratory Test Values |
1; 4; 4; 0; 4; 5 | — |
| SECONDARY Frequency (Occurrence Rates) of a Composite Clinical Endpoint. |
0; 0; 1.6 | — |
| SECONDARY Frequency (Occurrence Rates) of Ischemic or Haemorrhagic Stroke (Fatal or Non-fatal) |
0; 0; 1.6 | — |
| SECONDARY Frequency (Occurrence Rates) of Transient Ischemic Attack |
0; 0; 0 | — |
| SECONDARY Frequency (Occurrence Rates) of Systemic Embolism |
0; 0; 0 | — |
| SECONDARY Frequency (Occurrence Rates) of Myocardial Infarction (Fatal or Non-fatal) |
0; 0; 0 | — |
| SECONDARY Frequency (Occurrence Rates) of Other Major Adverse Cardiac Events |
0; 0; 0 | — |
| SECONDARY Frequency (Occurrence Rates) of Death |
0; 0; 0 | — |
| SECONDARY Anticoagulation Effects Trough aPTT (Activated Partial Thromboplastin Time) |
32.4; 34.0; 40.2; 45.0; 40.9; 45.0 | — |
| SECONDARY Anticoagulation Effects Trough ECT (Ecarin Clotting Time) |
35.6; 36.3; 53.4; 63.2; 51.4; 58.9 | — |
| SECONDARY Anticoagulation Effects Trough INR (International Normalised Ratio) |
1.87; 2.03; 1.35; 1.49; 1.35; 1.46 | — |
| SECONDARY Anticoagulation Effects Trough 11-dehydrothromboxane B2 |
2730; 3190; 3080; 1890; 1480; 1660 | — |
| SECONDARY Steady-state Pharmacokinetics of Total Dabigatran Trough Plasma Concentration |
53.1; 78.1; 55.6; 78.2; 63.0; 75.1 | — |
Eligibility Criteria
Inclusion criteria Inclusion criteria
- Patients with non-valvular atrial fibrillation (paroxysmal, persistent or permanent)
- Patients who had additional risk factor for thromboembolism; one or more of the following conditions/events:
- Hypertension
- Diabetes mellitus
- Left-side heart failure
- A previous ischemic stroke or transient ischemic attack
- Age 75 years or older
- A history of coronary artery diseases
Exclusion criteria Exclusion criteria
- Patients diagnosed as having a valvular heart disease by echocardiography, or patients who had a history of prosthetic valve replacement or valve surgery
- Patients who were to receive electric defibrillation or pharmacological defibrillation during the study period
- Patients who developed stroke or transient ischemic attack within 30 days before the date of informed consent
- Patients who developed myocardial infarction or were admitted to hospital due to acute coronary syndrome or for percutaneous transluminal coronary angioplasty within 3 months before the date of informed consent or patients underwent coronary stenting within 6 months before the date of informed consent
- Patients with atrial myxoma or left ventricular thrombosis
- Patients with contraindication to anticoagulant therapies
- Patients scheduled for major surgery or invasive procedure
- Patients having major bleeding from non-gastrointestinal organs within 6 months before the date of informed consent
- Patients with uncontrolled hypertension
Data sourced from ClinicalTrials.gov (NCT01136408). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.