Ticagrelor Monotherapy Compared to Aspirin Monotherapy in Patients With History of ACS (FMD_ACS)

This is an interventional treatment trial for Acute Coronary Syndrome Read More

Inclusion Criteria:

1. Men and women aged 18 years or above.
2. Documented history of presumed spontaneous ACS (excluding known peri-procedural or definite secondary MI [eg, due to profound hypotension, hypertensive emergency, tachycardia, or profound anemia]) with their most recent MI occurring 18 months or more prior to randomization
3. Patient currently prescribed and tolerating ASA
4. Females of child-bearing potential (ie, who are not chemically or surgically sterilized or who are not post-menopause) must have a negative urine pregnancy test at enrollment (to be confirmed by blood pregnancy test at the central lab.) Females of child-bearing potential must be willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator.
5. Written informed consent prior to any study specific procedures.

Exclusion Criteria:

1. Recurrent cardiovascular event (ACS, stroke and unplanned revascularization) after the index ACS
2. Planned use of ADP receptor blockers (eg, clopidogrel, ticlopidine, prasugrel), dipyridamole, or cilostazol
3. Planned coronary, cerebrovascular, or peripheral arterial revascularization
4. Concomitant oral or intravenous therapy with strong cytochrome P450 3A (CYP3A) inhibitors, CYP3A substrates with narrow therapeutic indices, or strong CYP3A inducers which cannot be stopped for the course of the study - Strong inhibitors: ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin (but not erythromycin or azithromycin), nefazadone, ritonavir, saquinavir, nelfinavir, indinavir, atanazavir, over 1 litre daily of grapefruit juice - Substrates with narrow therapeutic index: cyclosporine, quinidine, simvastatin at doses >40 mg daily or lovastatin at doses >40 mg daily
5. Concomitant use of vasoactive drugs or vasoactive drugs cannot be stopped.
6. Need for chronic oral anticoagulant therapy or chronic low-molecular-weight heparin (at venous thrombosis treatment not prophylaxis doses)
7. Patients with known bleeding diathesis or coagulation disorder

8. Patients with:

   • Concomitant active pathological bleeding,
   • A history of intracranial bleed at any time,
   • A central nervous system tumour or intracranial vascular abnormality (eg, aneurysm, arteriovenous malformation) at any time,
   • Intracranial or spinal cord surgery within 5 years, or
   • A gastrointestinal (GI) bleed within the past 6 months, or major surgery within 30 days
9. History of ischemic stroke at any time
10. Patients considered to be at risk of bradycardic events ([eg, known sick sinus syndrome or second or third degree atrioventricular (AV) block]) unless already treated with a permanent pacemaker
11. Coronary-artery bypass grafting in the past 5 years, unless the patient has experienced a spontaneous MI subsequent to the bypass surgery.
12. Known severe liver disease (eg, ascites or signs of coagulopathy)
13. Renal failure requiring dialysis or anticipated need for dialysis during the course of the study
14. Hypersensitivity to ticagrelor or any excipients
15. Pregnancy or lactation
16. Life expectancy < 1 year
17. Any condition which in the opinion of the Investigator would make it unsafe or unsuitable for the patient to participate in this study (eg, active malignancy other than squamous cell or basal cell skin cancer)
18. Concern for inability of the patient to comply with study procedures and/or follow up (eg, alcohol or drug abuse)
19. Participation in previous study with ticagrelor if treated with ticagrelor. Previous randomization in the present study
20. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
21. Participation in another clinical study with an investigational product during the preceding 30 days