RIDGEFIELD, Conn., -- Boehringer Ingelheim announced today that the first U.S. patients have been enrolled in two of the company's international clinical trials, RE-DUAL PCI™ (NCT02164864) and RE-CIRCUIT™ (NCT02348723). RE-DUAL PCI will evaluate the efficacy and safety of Pradaxa® (dabigatran etexilate mesylate) in patients with non-valvular atrial fibrillation (NVAF) who have undergone percutaneous coronary intervention (PCI), also known as angioplasty, with stent placement. RE-CIRCUIT will evaluate the safety of PRADAXA in NVAF patients undergoing a first ablation procedure, which is conducted to help prevent heart rhythm problems.
"Despite current strategies for reducing vascular risk factors in NVAF, there is still a need to decrease the risk of stroke in patients requiring anticoagulation during interventions such as PCI and ablation," said Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "The initiation of these two studies reinforces Boehringer Ingelheim's commitment to examining appropriate anticoagulation with PRADAXA to improve outcomes in patients undergoing these procedures."
Both trials are part of Boehringer Ingelheim's extensive RE-VOLUTION® clinical trial program for PRADAXA. The program includes 14 studies and is expected to involve more than 50,000 patients in more than 44 countries globally. PRADAXA was initially approved by the FDA in 2010 to reduce the risk of stroke and systemic embolism in patients with NVAF. In 2014, the FDA approved two additional indications for PRADAXA for the treatment of DVT and PE in patients who have been treated with a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated.
About RE-DUAL PCI™
Randomized Evaluation of DUAL Therapy with Dabigatran vs. Triple Therapy with Warfarin in Patients with NVAF That Have Undergone PCI with Stenting
RE-DUAL PCI is an event-driven, open label trial and will evaluate dual therapy of PRADAXA (150 mg or 110 mg twice daily) plus single antiplatelet therapy (clopidogrel or ticagrelor) compared to the current standard of care of triple therapy, which includes warfarin plus two antiplatelet agents (clopidogrel or ticagrelor, and aspirin in the trial). The trial will enroll an estimated 8,520 NVAF patients at 401 study locations around the globe.
"Currently there are limited data about appropriate anticoagulation treatment for patients with NVAF undergoing PCI, but with the plan to enroll more than 8,500 patients, we expect RE-DUAL PCI to provide robust data to help us better understand and care for this patient population," said Christopher Cannon, M.D., RE-DUAL PCI lead investigator, cardiologist, Brigham and Women's Hospital inBoston and Professor of Medicine, Harvard Medical School.
The primary efficacy endpoint of the trial is the time to death or first thrombotic event (all death, myocardial infarction, stroke or systemic embolism). The primary safety endpoint is the time to first major bleeding event, as defined by the International Society of Haematology (ISTH). Secondary endpoints include time to the individual events included in the primary efficacy endpoint, as well as time to:
All endpoints will be assessed at time points up to 30 months following randomization to the three treatment groups. Results of the study are expected in 2017.
About RE-CIRCUIT™
Randomized Evaluation of Dabigatran Etexilate Compared to WarfarIn in Pulmonary Vein Ablation: Assessment of Different Peri-procedUral Anticoagulation Strategy
The open label RE-CIRCUIT study will evaluate the safety of uninterrupted treatment with PRADAXA 150 mg twice daily compared to uninterrupted warfarin (International Normalized Ratio [INR] of 2.0 to 3.0) in NVAF patients undergoing a first ablation procedure. The trial will enroll an estimated 724 patients at 85 international study locations.
"The RE-CIRCUIT trial provides an important opportunity to expand knowledge and the potential to help inform guidelines for appropriate use of novel oral anticoagulants in NVAF patients undergoing ablation procedures," said Dr. Hugh Calkins, Chairman of the RE-CIRCUIT Study Steering Committee and Professor of Cardiology and Director of the Electrophysiology Laboratory and Arrhythmia Service, Johns Hopkins Hospital, Baltimore, Maryland.
The primary endpoint is the incidence of major bleeding events, as defined by the International Society of Haematology (ISTH). Secondary efficacy and safety endpoints include:
All endpoints will be assessed at time points during ablation and up 2 months post ablation.
About PCI
PCI is a general term to describe non-surgical revascularization procedures of the coronary arteries to improve blood flow in the heart. A small, flexible tube (catheter) with an attached deflated balloon is threaded through a coronary artery and inflated to widen areas where blood flow has been reduced or blocked. PCI often also involves placement of a stent to help prop the artery open and decrease the chance of another blockage.
Approximately 600,000 PCI procedures are performed in the United States each year; an estimated 5 to 7 percent involve patients with atrial fibrillation (AFib) or another condition requiring anticoagulant therapy. Research currently shows that about one in every 20 patients undergoing PCI also show a need for anticoagulant therapy to reduce their risk of stroke due to either AFib or another condition.
About Ablation
Ablation, also called radiofrequency ablation, uses catheters threaded through blood vessels in the legs and into the inner heart, where the catheters transmit energy to correct structural problems that cause an abnormal heart rhythm (arrhythmias). An irregular heartbeat increases the risk of an ischemic, or clot-based, stroke by up to five times. Ablation is effective at restoring a patient's normal heart rhythm, but the procedure itself may temporarily increase the risk of blood clots. An estimated 50,000 AFib ablations were performed in the United States in 2013.
About Pradaxa® (dabigatran etexilate mesylate) Capsules Indications and Usage
Pradaxa® (dabigatran etexilate mesylate) capsules is indicated:
IMPORTANT SAFETY INFORMATION ABOUT PRADAXA |
WARNING: (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS, (B) SPINAL/EPIDURAL HEMATOMA |
(A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS |
CONTRAINDICATIONS
PRADAXA is contraindicated in patients with:
- active pathological bleeding;
- known serious hypersensitivity reaction (e.g., anaphylactic reaction or anaphylactic shock)
to PRADAXA;
- mechanical prosthetic heart valve
WARNINGS & PRECAUTIONS
Increased Risk of Thrombotic Events after Premature Discontinuation
Premature discontinuation of any oral anticoagulant, including PRADAXA, in the absence of adequate alternative anticoagulation increases the risk of thrombotic events. If PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant.
Risk of Bleeding
Thromboembolic and Bleeding Events in Patients with Prosthetic Heart Valves
The use of PRADAXA is contraindicated in patients with mechanical prosthetic valves due to a higher risk for thromboembolic events, especially in the post-operative period, and an excess of major bleeding for PRADAXA vs. warfarin. Use of PRADAXA for the prophylaxis of thromboembolic events in patients with AFib in the setting of other forms of valvular heart disease, including bioprosthetic heart valve, has not been studied and is not recommended.
Effect of P-gp Inducers & Inhibitors on Dabigatran Exposure
Concomitant use of PRADAXA with P-gp inducers (e.g., rifampin) reduces exposure to dabigatran and should generally be avoided. P-gp inhibition and impaired renal function are major independent factors in increased exposure to dabigatran. Concomitant use of P-gp inhibitors in patients with renal impairment is expected to increase exposure of dabigatran compared to either factor alone.
Reduction of Risk of Stroke/Systemic Embolism in NVAF
Treatment and Reduction in the Risk of Recurrence of DVT/PE
ADVERSE REACTIONS
The most serious adverse reactions reported with PRADAXA were related to bleeding.
NVAF
DVT/PE
Drug hypersensitivity reactions were reported in ≤ 0.1% of patients receiving PRADAXA.
Other Measures Evaluated
In NVAF patients, a higher rate of clinical MI was reported in patients who received PRADAXA (0.7/100 patient-years for 150 mg dose) than in those who received warfarin (0.6).
Please see full Prescribing Information, including boxed WARNING and Medication Guide.
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About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation (Ridgefield, CT) and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 142 affiliates and more than 47,400 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.
Social responsibility is a central element of Boehringer Ingelheim's culture. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.
In 2013, Boehringer Ingelheim achieved net sales of about $18.7 billion (14.1 billion euro). R&D expenditure in the Prescription Medicines business corresponds to 19.5% of its net sales.
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Boehringer Ingelheim Pharmaceuticals, Inc. either owns or uses the trademarks Pradaxa®, PRADAXA with associated design®, RE-DUAL PCI™ and RE-CIRCUIT™ under license.
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