Status:
COMPLETED
Low Dose Ticagrelor Versus Low Dose Prasugrel in Patients With Prior Myocardial Infarction
Lead Sponsor:
Attikon Hospital
Conditions:
Myocardial Infarction
Diabetes Mellitus
Eligibility:
All Genders
50-90 years
Phase:
PHASE4
Brief Summary
Taken together the results from DAPT and PEGASUS-TIMI54, it appears that physicians may consider extending beyond 1 year or reinitiating treatment with a thienopyridine or ticagrelor 60mg bid in patie...
Detailed Description
This is a prospective, randomized, single blind, single center, crossover study. Eligible patients undergoing P2Y12 receptor antagonist therapy before screening will undergo a 14-day minimum washout p...
Eligibility Criteria
Inclusion
- Provision of informed consent prior to any study specific procedures
- Post-menopausal female (defined as absence of any vaginal bleeding for a year) or male aged \>50 years
- A spontaneous MI (ST or Non ST segment elevation) 1 to 3 years before enrolment. In addition, at least one of the following high-risk features: age of 65 years or older, diabetes mellitus requiring medication, a second prior spontaneous MI, multivessel coronary artery disease, or non-end stage renal disease (estimated creatinine clearance of \<60 ml per minute).
Exclusion
- Planned use of a P2Y12 receptor antagonist, dipyridamole, cilostazol, or anticoagulant therapy during the study period;
- Known allergy, intolerance, hypersensitivity to ticagrelor or prasugrel or any excipients,
- Active pathological bleeding, severe hepatic impairment, a bleeding disorder or a history of an ischemic stroke or intracranial bleeding, a central nervous system tumor, or an intracranial vascular abnormality;
- Gastrointestinal bleeding within the previous 6 months or major surgery within the previous 30 days;
- Concomitant use of potent Cytochrome P450 3A4 (CYP3A4) inhibitors (atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin and voriconazole, grapefruit juice over 1 litre daily), CYP3A substrates with narrow therapeutic indices (cyclosporine, quinidine), or inducers (carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampin, and rifapentine).
- Increased risk of bradycardic events (e.g. known sick sinus syndrome or third degree AV block or previous documented syncope suspected to be due to bradycardia unless treated with a pacemaker).
- Inability to adhere to the follow-up requirements or any other reason or condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated.
Key Trial Info
Start Date :
January 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03387826
Start Date
January 11 2018
End Date
January 31 2019
Last Update
March 5 2019
Active Locations (1)
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1
Attikon University Hospital
Chaïdári, Greece, 12462