First patients enrolled in study to evaluate dabigatran etexilate after PCI with stenting

Boehringer Ingelheim today announces that the first patients have been enrolled in the company’s new international phase III study, RE-DUAL PCI™.¹ The study will evaluate the efficacy and safety of the oral anticoagulant dabigatran etexilate in patients with an irregular heartbeat called non-valvular atrial fibrillation (AF), who have undergone a percutaneous coronary intervention (PCI) with stent placement to widen their blocked coronary arteries.² RE-DUAL PCITM aims to advance medical knowledge and guide future antithrombotic treatment choice for greatest patient benefit. It addresses the need for innovative new treatment regimens to improve patient prognosis.

AF is associated with a risk of stroke caused by blood clots from the heart.³ PCI, also known as angioplasty, is a medical procedure where a stent (a small mesh tube) is used to widen the arteries of the heart to restore or improve blood flow in patients with coronary artery disease.⁴ However the procedure is also associated with a risk of serious complications caused by blood clots, including stroke and other major adverse cardiac events.^5,6 Patients with AF who undergo PCI are thus at special risk of these complications. To prevent them, patients receive antithrombotic therapy. Current standard care is linked to an increased risk of bleeding, because it currently involves taking three antithrombotic treatments together, one of them an anticoagulant.⁷

“Currently there are limited data about appropriate anticoagulation treatment in patients with AF undergoing PCI,” said Professor Christopher Cannon, RE-DUAL PCITM Lead Investigator and Executive Director, Cardiometabolic Trials, Harvard Clinical Research Institute.”We expect this study to provide data that can help us better understand how to prevent stroke and stent thrombosis while at the same time minimising bleeding risk in this especially vulnerable patient population,” said Cannon, who also is a cardiologist at Brigham and Women’s Hospital in Boston and a Professor of Medicine, Harvard Medical School.

The RE-DUAL PCI™ study will compare the efficacy and safety of dual antithrombotic therapy with dabigatran etexilate (110mg or 150mg twice daily) plus clopidogrel or ticagrelor versus the currently recommended standard triple antithrombotic therapy regimen with warfarin (INR 2.0 – 3.0) plus clopidogrel or ticagrelor plus acetylsalicylic acid.² The study will enroll approximately 8,500 patients at 700 sites in over 40 countries around the globe.¹ Boehringer Ingelheim is conducting the study cooperatively with the Harvard Clinical Research Institute.

“Boehringer Ingelheim is confident in the ability of dabigatran etexilate to safely reduce the risk of thromboembolic events when used as directed and is committed to expanding the scientific knowledge of dabigatran use in AF patients who undergo significant procedures for their cardiac conditions,” said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. “We look forward to the continuing enrollment of patients in RE-DUAL PCI™ and expect to have full results in 2017.”

RE-DUAL PCI™ is part of Boehringer Ingelheim’s extensive clinical trial program, RE-VOLUTION™. With the recently announced RE-CIRCUIT™ and RE-SPECT ESUS™ studies, the entire programme will include 15 clinical trials involving over 60,000 patients in more than 100 countries globally.^2,8-20

References

1. Boehringer Ingelheim Data on File.
2. Clinical Trials.gov. Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting. http://clinicaltrials.gov/ct2/show/NCT02164864?term=dabigatran+etexilate&recr=Open&rank=6 Last accessed July 2014.
3. Camm AJ, et al. 2012 focused update of the ESC Guidelines for the management of atrial fibrillation. Eur Heart J. 2012;33(21):2719-47.
4. Mayo Clinic. Coronary angioplasty and stents. http://www.mayoclinic.org/tests-procedures/angioplasty/basics/definition/prc-20014401 Last accessed July 2014.
5. Faxon DP. et al. Consensus Document: Antithrombotic therapy in patients with atrial fibrillation undergoing coronary stenting. Thromb Haemost. 2011;106:571–84.
6. Chan W. et al. Impact of Periprocedural Atrial Fibrillation on Short-Term Clinical Outcomes Following Percutaneous Coronary Intervention. American Journal of Cardiology. 2012;109(4):471-477.
7. DeWilde W. et al. Use of clopidogrel with or without aspirin in patients taking oral anticoagulant therapy and undergoing percutaneous coronary intervention: an open-label, randomised, controlled trial. Lancet. 2013;381:1107–15.
8. Connolly SJ, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139-51.
9. Connolly SJ, et al. Newly identified events in the RE-LY trial. N Engl J Med. 2010;363:1875-6.
10. Connolly SJ, et al. The Long Term Multi-Center Extension of Dabigatran Treatment in Patients with Atrial Fibrillation (RELY-ABLE) study. Circulation. 2013;128:237-43.
11. Eriksson BI, et al. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet. 2007;370:949–56.
12. Eriksson BI, et al. Oral dabigatran versus enoxaparin for thromboprophylaxis after primary total hip arthroplasty (RE-NOVATE II*). A randomised, doubleblind, non-inferiority trial. Thromb Haemost. 2011;105:721-9.
13. Eriksson BI, et al. Oral dabigatran etexilate vs. subcutaneous enoxaparin for the prevention of venous thromboembolism after total knee replacement: the RE-MODEL randomized trial. Thromb Haemost. 2007;5:2178–85.
14. Schulman S, et al. Dabigatran versus warfarin in the Treatment of Acute Venous Thromboembolism. N Engl J Med. 2009;361:2342–52.
15. Schulman S, et al. Treatment of Acute Venous Thromboembolism with Dabigatran or Warfarin and Pooled Analysis. Circulation. 2014;129:764-772
16. Schulman S, et al. Extended use of dabigatran, warfarin or placebo in venous thromboembolism. N Engl J Med. 2013;368:709–18.
17. Oldgren J. et al. Dabigatran vs. placebo in patients with acute coronary syndromes on dual antiplatelet therapy: a randomized, double-blind, phase II trial. Eur Heart J. 2011;32:2781-9.
18. Diener H-C, et al. Rationale, objectives and design of a secondary stroke prevention study of dabigatran etexilate versus acetylsalicylic acid in patients with embolic stroke of undetermined source (RE-SPECT-ESUS). Presented at the European Stroke Conference, Nice, France on 7 May 2014, 12:45-14:15 PM.
19. Ginsberg JS, et al. Oral thrombin inhibitor dabigatran etexilate vs North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery. J Arthoplasty. 2009;24:1–9.
20. Boehringer Ingelheim Press Release – New Pradaxa® clinical study to explore practical management of patients with atrial fibrillation undergoing ablation. http://www.newshome.com/diru/news_releases/press_releases/2014/20_june_2014_dabigatranetexilate.html Last accessed August 2014.