Up-to-date List of Pradaxa Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Pradaxa Medical Research Studies

RankStatusStudy
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

These studies may lead to new treatments and are adding insight into Pradaxa etiology and treatment.

A major focus of Pradaxa research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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