Health Condition 1: null- Non-Valvular Atrial Febrillation that have undergone Percutaneous Coronary Intervention with stenting
Conditions
Interventions
Intervention1: Pradexa
Dabigatran Etexilate: Oral Capsules
1 x 110mg capsule b.i.d. (total daily dose 220mg)
1 x 150mg capsule b.i.d. (total daily dose 300mg). This event driven trial is expected to take place over 30 mont
Warfarin: Oral Tablets, 1mg
3mg
5mg, As needed to maintain a target INR of 2.0- 3.0 (2.0-2.5 if feasible). This event driven trial is expected to take place over 30 months
Sponsors
Boehringer Ingelheim Pharmaceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male or female patients aged 18 years and more 2 Patients with NVAF that have been receiving oral anticoagulant treatment (either with warfarin, another VKA or other novel oral anticoagulant), or were treatment naïve prior to PCI. AF may be paroxysmal, persistent or permanent, but must not be secondary to a reversible disorder such as MI, pulmonary embolism, recent surgery, pericarditis or thyrotoxicosis, unless long term oral anticoagulation is planned. 3 Patient presenting with: An ACS (STEMI, NonSTEMI [NSTEMI] or unstable angina [UA]) that was successfully treated by PCI and stenting (either BMS or DES) 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) 4 The patient must be able to give informed consent in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) guidelines and local legislation and/or regulations
Exclusion criteria
Exclusion criteria: The patient must not meet any of the exclusion criteria: Patients with a mechanical or biological heart valve prosthesis 2. Cardiogenic shock during current hospitalisation 3. Patients who have used fibrinolytic agents within 24 hours of randomisation that, in the opinion of the Investigator, will put the patient at high risk of bleeding 4. Stroke within 1 month prior to screening visit 5. Patients, who in the opinion of the Investigator, have had major surgery within the month prior to screening 6. Patient has received an organ transplant or is on a waiting list for an organ transplant 7. History of intraocular, spinal, retroperitoneal or a traumatic intra-articular bleeding unless the causative factor has been permanently eliminated or repaired (e.g. by surgery) 8. Gastrointestinal (GI) haemorrhage within one month prior to screening, unless, in the opinion of the Investigator, the cause has been permanently eliminated (e.g. by surgery) Major bleeding episode (reduction in the haemoglobin level of at least 2g/dL, transfusion of at least two units of blood, or symptomatic bleeding in a critical area or organ) including life-threatening bleeding episode (symptomatic intracranial bleeding, bleeding with a decrease in the haemoglobin level of at least 5g/dL or bleeding requiring transfusion of at least 4 units of blood or inotropic agents or necessitating surgery) in one month prior to screening visit 10. Haemorrhagic disorder or bleeding diathesis (e.g. von Willebrand disease, haemophilia A or B or other hereditary bleeding disorder, history of spontaneous intra-articular bleeding, history of prolonged bleeding after surgery/intervention) 11. Anaemia (haemoglobin thrombocytopenia (platelet count 12. Severe renal impairment (estimated CrCl calculated by Cockcroft-Gault equation) 13. Active liver disease as indicated by at least one of the following: ï?· Prior and persistent alanine aminotransferase (ALT) or Aspartate transaminase (AST) or alkaline phosphatase (AP) >3 ï?´ upper limit of normal (ULN)1 ï?· Known active hepatitis C ï?· Known active hepatitis B ï?· Known active hepatitis A 14. Recent malignancy or radiation therapy ( Investigator, the estimated life expectancy is greater than 36 months 15. Need for continued treatment with systemic ketoconazole, itraconazole, posaconazole, cyclosporine, tacrolimus, dronedarone, rifampicin, phenytoin, carbamazepine, St. Johnâ??s Wort. See Section 4.2.2 16. Patients who, in the Investigatorâ??s opinion, need continuous treatment with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) 17. Patients with a known allergy to dabigatran etexilate or to the excipients used for the capsule of the drug 18. Patients with a known allergy to warfarin tablets or to the excipients 19. Patients who, in the Investigatorâ??s opinion, should not be treated with OAC 20. Patients with a contraindication to clopidogrel, ticagrelor or ASA Pre-menopausal women (last menstruation ï?· Are pregnant or br
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The dual primary endpoints for this trial are a composite endpoint of efficacy and a safety endpoint: 1. Time to death or first thrombotic event (DTE) (all death, MI, stroke/SE) 2. Time to first ISTH Major Bleeding Event (MBE)Timepoint: End of study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Individual outcome events-All death, MI, stroke, SE, Stent thrombosis 2. Composite endpoint of death and MI and stroke 3. Repeated revascularisation by PCI or CABGTimepoint: End of study | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Republic of Korea, Singapore, Slovakia, Slovenia, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, United States of America
Contacts
Public ContactDr Partha Gokhale
Boehringer Ingelheim Pvt Ltd
Outcome results
None listed