Randomized, Open Label Study of Dabigatran Etexilate in Elective Percutaneous Coronary Intervention
Summary
To assess whether two doses of dabigatran etexilate (110 mg b.i.d and 150 mg b.i.d) as compared to UFH, both in addition to a standard dual antiplatelet regimen, provide sufficient anticoagulation in the setting of elective PCI.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Heart Catheterization
Intervention
dabigatran 110 mg, dabigatran 150 mg, unfractionated heparin
Location
1160.73.31004 Boehringer Ingelheim Investigational Site
Alkmaar
Netherlands
Status
Recruiting
Source
Boehringer Ingelheim Pharmaceuticals
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00818753
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Heparin, Low-molecular-weight
Heparin fractions with a molecular weight usually between 4000 and 6000 kD. These low-molecular-weight fractions are effective antithrombotic agents. Their administration reduces the risk of hemorrhage, they have a longer half-life, and their platelet interactions are reduced in comparison to unfractionated heparin. They also provide an effective prophylaxis against postoperative major pulmonary embolism.
Heparin Antagonists
Coagulant substances inhibiting the anticoagulant action of heparin.
Radionuclide Ventriculography
Imaging of a ventricle of the heart after the injection of a radioactive contrast medium. The technique is less invasive than cardiac catheterization and is used to assess ventricular function.
Nadroparin
A heparin fraction with a mean molecular weight of 4500 daltons. It is isolated from porcine mucosal heparin and used as an antithrombotic agent. (From Merck Index, 11th ed)
Protamines
A group of simple proteins that yield basic amino acids on hydrolysis and that occur combined with nucleic acid in the sperm of fish. Protamines contain very few kinds of amino acids. Protamine sulfate combines with heparin to form a stable inactive complex; it is used to neutralize the anticoagulant action of heparin in the treatment of heparin overdose. (From Merck Index, 11th ed; Martindale, The Extra Pharmacopoeia, 30th ed, p692)
Clinical Trials
The purposes of this study are: 1. To evaluate the long-term safety of dabigatran etexilate 2. To assess the effect of a knowledge translation intervention on patient outcomes
Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate
The primary objective of this trial is to demonstrate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and sys...
Dabigatran Etexilate Compared With Enoxaparin in Prevention of VTE Following Total Hip Arthroplasty
The primary objective of the trial is to demonstrate non-inferiority of 220 mg oral dabigatran etexilate compared to 40 mg subcutaneous enoxaparin administered once daily. Safety and effic...
Safety and Tolerability of Dabigatran Etexilate in Adolescents
To investigate the safety and tolerability of dabigatran etexilate capsules in a small group of eight adolescent patients.
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...
PubMed Articles
INTRODUCTION: Lifelong oral anticoagulation (OAC) therapy is required for the prevention of thromboembolic events after implantation of an artificial heart valve. Thromboembolism and anticoagulant-rel...
PURPOSE: Effective intraprocedural anticoagulation for catheter ablation for atrial fibrillation is critical to minimize the risk of cerebral thromboembolism. The effect of dabigatran on anticoagulati...
Aims: Patients receiving long-term anticoagulant treatment with dabigatran may need to undergo a percutaneous coronary intervention (PCI). We studied markers of coagulation activation during elective...
BACKGROUND: The usefulness of dabigatran etexilate for the prevention of stroke in patients with atrial fibrillation (AF) has been reported. OBJECTIVES: In this study the efficacy and safety of dabiga...
Dabigatran: An Oral Novel Potent Reversible Nonpeptide Inhibitor of Thrombin.
Dabigatran is a highly selective, reversible, and potent thrombin inhibitor and is orally available as the prodrug, dabigatran etexilate. It has shown antithrombotic efficacy in animal models of throm...
