This is a prospective, randomised, open label, blinded endpoint (PROBE), active comparator (warfarin) trial which will evaluate Dual Antithrombotic Therapy vs. Triple Antithrombotic Therapy in NVAF patients undergoing PCI Stenting
- Conditions
- Health Condition 1: null- Non-Valvular Atrial Febrillation that have undergone Percutaneous Coronary Intervention with stenting
- Registration Number
- CTRI/2015/05/005794
- Lead Sponsor
- Boehringer Ingelheim Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 35
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
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 <10g/dL) or thrombocytopenia including heparin-induced
thrombocytopenia (platelet count <100 ï?´ 109/L) at screening (Visit 1)
12. Severe renal impairment (estimated CrCl calculated by Cockcroft-Gault equation)
<30mL/min at screening (Visit 1)
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 (<=6 months) unless, in the opinion of the
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 <=1 year prior to screening) who:
ï?· Are pregnant or br
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The dual primary endpoints for this trial are a composite endpoint of efficacy and a safety <br/ ><br>endpoint: <br/ ><br>1. Time to death or first thrombotic event (DTE) (all death, MI, stroke/SE) <br/ ><br>2. Time to first ISTH Major Bleeding Event (MBE)Timepoint: End of study
- Secondary Outcome Measures
Name Time Method 1. Individual outcome events-All death, MI, stroke, SE, Stent thrombosis <br/ ><br>2. Composite endpoint of death and MI and stroke <br/ ><br>3. Repeated revascularisation by PCI or CABGTimepoint: End of study