Phase 3
Completed N=2,725
Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)
Source: ClinicalTrials.gov NCT02164864 ↗Enrolled (actual)
2,725
Serious AEs
41.5%
Results posted
Jul 2018
Primary outcomePrimary: Time to First Adjudicated ISTH MBE or CRNMBE — 151; 154; 264; 196 Participants — p=<0.0001
◆ Published Evidence
Established
24citations · ~4 / year
Effect of Lesion Complexity and Clinical Risk Factors on the Efficacy and Safety of Dabigatran Dual Therapy Versus Warfarin Triple Therapy in Atrial Fibrillation After Percutaneous Coronary Intervention: A Subgroup Analysis From the REDUAL PCI Trial.
Summary
The main objective of this study is to compare a Dual Antithrombotic Therapy (DAT) regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg dabigatran etexilate (DE) DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (150mg DE-DAT) with a Triple Antithrombotic Therapy (TAT) combination of warfarin plus clopidogrel or ticagrelor plus Aspirin (ASA) <= 100mg once daily (warfarin-TAT) in patients with Atrial Fibrillation that undergo a PCI with stenting (elective or due to an Acute Coronary Syndrome).
The study aims to show non-inferiority of each dose of DE-DAT when compared to Warfarin-TAT in terms of safety. Safety will be determined by comparing the rates of bleeding events, assessed using the modified International Society of Thrombosis and Haemostasis classification of Major Bleeding and Clinically Relevant Non Major Bleeding Events.
Linked Publications (5)
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Effect of Lesion Complexity and Clinical Risk Factors on the Efficacy and Safety of Dabigatran Dual Therapy Versus Warfarin Triple Therapy in Atrial Fibrillation After Percutaneous Coronary Intervention: A Subgroup Analysis From the REDUAL PCI Trial.
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Dabigatran Dual Therapy vs Warfarin Triple Therapy Post-Percutaneous Coronary Intervention in Patients with Atrial Fibrillation With/Without a Proton Pump Inhibitor: A Pre-Specified Analysis of the RE-DUAL PCI Trial.
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Renal Function and Outcomes With Dabigatran Dual Antithrombotic Therapy in Atrial Fibrillation Patients After PCI.
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Safety and efficacy of non-vitamin K oral anticoagulant for atrial fibrillation patients after percutaneous coronary intervention: A bivariate analysis of the PIONEER AF-PCI and RE-DUAL PCI trial.
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Comparison of Dabigatran Plus a P2Y<sub>12</sub> Inhibitor With Warfarin-Based Triple Therapy Across Body Mass Index in RE-DUAL PCI.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Adjudicated ISTH MBE or CRNMBE |
151; 154; 264; 196 | <0.0001 sig |
| SECONDARY Time to Adjudicated Undetermined Cause of Death |
4; 5; 4; 3 | 0.9862 |
| SECONDARY Time to Adjudicated Non-CV |
14; 4; 13; 8 | 0.8853 |
| SECONDARY Time to Adjudicated CV |
37; 21; 31; 24 | 0.5252 |
| SECONDARY Time to Adjudicated All Cause Death |
55; 30; 48; 35 | 0.5579 |
| SECONDARY Time to First Adjudicated MI |
44; 26; 29; 22 | 0.0861 |
| SECONDARY Time to First Adjudicated Stroke |
17; 9; 13; 8 | 0.4803 |
| SECONDARY Time to First Adjudicated SE |
3; 1; 3; 3 | 0.9388 |
| SECONDARY Time to First Adjudicated ST |
15; 7; 8; 7 | 0.1546 |
| SECONDARY Time to Composite Endpoint of Death + MI + Stroke |
107; 60; 80; 57 | 0.0484 sig |
| SECONDARY Time to Composite Endpoint of Death or First Thrombotic Event |
108; 60; 83; 60; 168 | 0.1128 |
| SECONDARY Time to First Adjudicated Unplanned Revascularisation by PCI/CABG |
76; 51; 69; 52 | 0.6080 |
| SECONDARY Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG |
149; 90; 131; 98; 239 | 0.0047 sig |
Eligibility Criteria
Inclusion criteria
- Male or female patients aged >=18 years
- Patients with Non Valvular Atrial Fibrillation
- Patient presenting with:
An Acute Coronary Syndrome (ACS) (ST elevation myocardial infarction (STEMI), NonSTEMI [NSTEMI] or unstable angina [UA]) that was successfully treated by PCI and stenting (either Bare Metal Stent (BMS) or Drug Eluting Stent) Or Stable Coronary Artery Disease with at least one lesion eligible for PCI that was successfully treated by elective PCI and stenting (either BMS or DES)
- The patient must be able to give informed consent in accordance with International Conference on Harmonisation Good Clinical Practice guidelines and local legislation and/or regulations.
Exclusion criteria
- Patients with a mechanical or biological heart valve prosthesis
- Cardiogenic shock during current hospitalisation
- Stroke within 1 month prior to screening visit
- Patients who have had major surgery within the month prior to screening
- Gastrointestinal haemorrhage within one month prior to screening, unless, in the opinion of the Investigator, the cause has been permanently eliminated
- Major bleeding episode including life-threatening bleeding episode in one month prior to screening visit
- Anaemia (haemoglobin <10g/dL) or thrombocytopenia including heparin-induced thrombocytopenia (platelet count <100 x 109/L) at screening
- Severe renal impairment (estimated Creatinine Clearance (CrCl) calculated by Cockcroft-Gault equation) <30mL/min at screening
- Active liver disease
Data sourced from ClinicalTrials.gov (NCT02164864) and the linked publication. 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.