| Rank |
Status |
Study |
| 1 |
Recruiting
|
Management of Myocardial Injury After Noncardiac Surgery Trial
| Condition: |
Myocardial Injury After Noncardiac Surgery (MINS) |
| Interventions: |
Drug: Dabigatran; Drug: Placebo (for Dabigatran); Drug: Omeprazole; Drug: Placebo (for Omeprazole) |
| Outcome Measures: |
Major vascular complication (for Dabigatran); Major upper gastrointestinal complication (for Omeprazole); Individual secondary outcomes for Dabigatran; Upper gastrointestinal complication for Omeprazole; Major vascular complication for Omeprazole; Individual secondary outcomes for Omeprazole; Safety outcomes for Dabigatran; Safety outcomes for Omeprazole |
|
| 2 |
Recruiting
|
Strategy of Continued Versus Interrupted Dabigatran at Time of Device Surgery in Patients With Moderate to High Risk of Arterial Thromboembolic Events
| Condition: |
Hematoma |
| Intervention: |
Drug: Dabigatran |
| Outcome Measures: |
Clinically significant hematoma; Composite of major peri-operative bleeding events and thrombo-embolic events |
|
| 3 |
Recruiting
|
Dabigatran Versus Warfarin After Mitral and/or Aortic Bioprosthesis Replacement and Atrial Fibrillation Postoperatively
| Condition: |
Primary Disease |
| Interventions: |
Drug: Dabigatran; Drug: Warfarin |
| Outcome Measures: |
Embolic Events; Bleeding |
|
| 4 |
Recruiting
|
SPARK: Safety Study of Pradaxa in Atrial Fibrillation Patients by Regulatory Requirement of Korea
| Condition: |
Atrial Fibrillation |
| Intervention: |
Drug: Pradaxa (Dabigatran etexilate mesilate) |
| Outcome Measures: |
Occurrence of adverse events; Incidence rate of stroke; Incidence rate of systemic embolism |
|
| 5 |
Recruiting
|
Drug Interaction Study Between Bosutinib And Dabigatran
| Condition: |
Healthy |
| Interventions: |
Drug: Dabigatran; Drug: Bosutinib |
| Outcome Measures: |
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast); Maximum Observed Plasma Concentration (Cmax); Time to Reach Maximum Observed Plasma Concentration (Tmax); Plasma Decay Half-Life (t1/2); Apparent Oral Clearance (CL/F); Apparent Volume of Distribution (Vz/F) |
|
| 6 |
Recruiting
|
Dabigatran's Effect on Changes in Atrial Fibrosis in Patients With Atrial Fibrillation
| Condition: |
Atrial Fibrillation |
| Intervention: |
Drug: Dabigatran etexilate (Pradaxa) |
| Outcome Measure: |
Percentage of fibrosis |
|
| 7 |
Recruiting
|
Dabigatran Treatment Following Transient Ischemic Attack and Minor Stroke
| Conditions: |
Transient Ischemic Attack; Minor Ischemic Stroke |
| Intervention: |
Drug: Dabigatran 110/150 mg BID |
| Outcome Measure: |
Symptomatic Hemorrhagic Transformation |
|
| 8 |
Recruiting
|
Use of Dabigatran Etexilate to Prevent Stroke and Thromboembolism
| Conditions: |
Atrial Fibrillation; Atrial Flutter |
| Intervention: |
Drug: dabigatran etexilate mesylate |
| Outcome Measures: |
Frequency of major bleeding complications and thrombo-embolic events in patients administered dabigatran following RF ablation.; Dabigatran serum drug levels in patients experiencing a major bleeding or thrombo-embolic event.; Frequency of minor bleeding events |
|
| 9 |
Recruiting
|
Pradaxa Study in Non-valvular Atrial Fibrillation Patients With Severely Impaired Renal Function
| Condition: |
Atrial Fibrillation |
| Intervention: |
Drug: Pradaxa, dabigatran etexilate |
| Outcome Measures: |
Pre-dose concentration of the analyte in plasma at steady state immediately before administration of the next dose; Concentration of analyte in plasma at steady state at 2 hours after administration of the last dose |
|
| 10 |
Recruiting
|
Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE)
| Condition: |
Venous Thromboembolism |
| Interventions: |
Drug: dabigatran etexilate; Drug: standard of care |
| Outcome Measures: |
First component of the co-primary endpoint: A combined efficacy endpoint of complete thrombus resolution plus freedom from recurrent VTE plus freedom from mortality related to VTE; Second component of the co-primary endpoint: Freedom from major bleeding events (a safety endpoint); Pharmacokinetic assessments (plasma concentrations of total dabigatran) 3 days after start of treatment (after at least six consecutive dabigatran doses) and after 3 days following any dabigatran dose adjustment; Frequency of dose adjustments; Frequency of switch of type of anti-coagulation therapy (including dabigatran to SOC) and a switch from an intended standard of care treatment to another; Freedom from thrombus progression at baseline and at days 21 and 84 after randomisation; Assessment of the acceptability of an age-appropriate formulation at end of therapy; Freedom from recurrence of VTE at 6, 9 and 12 months; Freedom from occurrence of post-thrombotic syndrome at 6, 9 and 12 months; All bleeding events; All-cause mortality; All components of the primary efficacy endpoints; Pharmacodynamic assessments (aPTT, ecarin clotting time (ECT) and dTT) 3 days after start of treatment (after at least six consecutive dabigatran doses) and after 3 days following any dabigatran dose adjustment; Frequency of temporary discontinuation from therapy; Frequency of permanent discontinuation from therapy; Number of laboratory monitoring requirements for dose adjustment during the treatment phase |
|
| 11 |
Recruiting
|
Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 12 Years of Age
| Condition: |
Venous Thromboembolism |
| Intervention: |
Drug: dabigatran etexilate |
| Outcome Measures: |
Plasma concentrations of total dabigatran; Plasma concentrations of free dabigatran; Plasma concentrations of BIBR 1048 BS (Base); Plasma concentrations of BIBR 951 BS; Plasma concentrations of BIBR 1087 SE (Acid); Activated prothrombin time (aPTT); Ecarin clotting time (ECT); Factor IIa inhibition; Incidence of all bleeding events; Incidence of all adverse events; Global assessment of tolerability will be summarized across all patients in the treated set; Patient assessment of taste will be summarized across all patients in the treated set; Changes in laboratory and clinical parameters |
|
| 12 |
Recruiting
|
Impact of Dabigatran and Phenprocoumon on Clopidogrel Mediated ADP Induced Platelet Aggregation in Patients With Atrial Fibrillation
| Conditions: |
Coronary Heart Disease; Atrial Fibrillation; Acute Coronary Syndrome; Atherosclerosis |
| Interventions: |
Drug: Dabigatran; Drug: Phenprocoumon |
| Outcome Measures: |
ADP induced platelet aggregation; Platelet function tests; Coagulation parameters |
|
| 13 |
Not yet recruiting
|
Validation of a Novel Dabigatran Based Peri-Operative Bridging Anticoagulation Protocol for Patients on Chronic Warfarin Therapy
| Condition: |
Venous Thrombembolic Events. |
| Intervention: |
Drug: Dabigatran. |
| Outcome Measure: |
Validation of a novel Dabigatran Based Peri-Operative Bridging Anticoagulation Protocol for Patients on Chronic Warfarin Therapy |
|
| 14 |
Not yet recruiting
|
Management of Major Bleeding Events in Atrial Fibrillation Patients Using Pradaxa
| Conditions: |
Atrial Fibrillation; Hemorrhage |
| Interventions: |
Drug: Dabigatran 75 mg; Drug: Dabigatran 150 mg |
| Outcome Measures: |
Number of patients with index event safety outcomes (ongoing/resolved/deceased); Number of patients receiving different types of interventions to stop the index events; Frequencies of bleeding types and anatomic locations of the index event |
|
| 15 |
Recruiting
|
Pharmacokinetics, Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 2 Years of Age
| Condition: |
Venous Thromboembolism |
| Intervention: |
Drug: dabigatran etexilate |
| Outcome Measures: |
Ecarin clotting time (ECT); Factor IIa inhibition; Incidence of all bleeding events; Incidence of all adverse events; Plasma concentrations of total dabigatran; Plasma concentrations of free dabigatran; Plasma concentrations of BIBR 1048 BS (Base); Plasma concentrations of BIBR 951 BS; Plasma concentrations of BIBR 1087 SE (Acid); Activated prothrombin time (aPTT); Global assessment of tolerability will be summarized across all patients in the treated set; Patient assessment of taste will be summarized across all patients in the treated set; Changes in laboratory and clinical parameters |
|
| 16 |
Recruiting
|
Safety Study of Dabigatran in CADASIL
| Condition: |
CADASIL |
| Interventions: |
Drug: Dabigatran; Drug: Antiplatelets |
| Outcome Measures: |
Number of microbleeds on MRI; Major bleeding |
|
| 17 |
Not yet recruiting
|
Cognitive Impairment Related to Atrial Fibrillation Prevention Trial
| Condition: |
Atrial Fibrillation |
| Interventions: |
Drug: Warfarin; Drug: Dabigatran |
| Outcome Measures: |
Cognitive impairment; Number of Participants with less important alteration in coagulation test as a Measure of Safety |
|
| 18 |
Recruiting
|
Reversal of Dabigatran Anticoagulant Effect With Idarucizumab
| Condition: |
Hemorrhage |
| Intervention: |
Drug: idarucizumab |
| Outcome Measures: |
Reversal of anticoagulant effect of dabigatran; Reversal of Activated Partial Thromboplastin Time (aPTT); Reversal of Thrombin Time (TT); Duration of reversal; Occurrence of major bleeding post-surgery (for Group B only); Time to cessation of bleeding (for Group A only); Minimum unbound sum (free) dabigatran; Reversal of diluted Thrombin Time (dTT) or Ecarin Clotting Time (ECT) after the first infusion and before the start of the second |
|
| 19 |
Recruiting
|
Pharmacogenomic Study on PKD/PKC of Dabigatran Etexilate and Rivaroxaban
| Condition: |
Healthy Volunteers |
| Interventions: |
Drug: D->R->C+R; Drug: D->R->C+D; Drug: R->D->C+D; Drug: R->D->C+R |
| Outcome Measures: |
AUC of plasma concentrations of the drugs; PKD of the drugs |
|
| 20 |
Recruiting
|
Pradaxa (Dabigatran Etexilate) 150 mg/q.d. in Patients With Moderate Renal Impairment After Hip or Knee Replacement Surgery
| Conditions: |
Arthroplasty, Replacement; Thromboembolism |
| Intervention: |
|
| Outcome Measures: |
Safety: Major bleeding events. Efficacy: composite of all death and documented symptomatic VTE (i.e documented symptomatic DVT and documented symptomatic nonfatal pulmonary embolism).; Major extra surgical site bleedings,volume of wound drainage, documented symptomatic proximal DVT, documented symptomatic distal DVT, documented symptomatic nonfatal pulmonary embolism and all-cause mortality |
|
