A study of two different strategies for handling anticlotting medication in patients who require open-heart surgery to bypass their blocked heart arteries following a heart attack
- Conditions
- Acute coronary syndromeCirculatory System
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 40
1. Provision of informed consent prior to any study-specific procedures
2. Male or female aged 18 years or over
3. Currently hospitalised for treatment of an acute coronary syndrome
4. Currently receiving aspirin 75 mg once daily
5. Current treatment or prior treatment during the current hospitalisation with ticagrelor 90 mg twice daily
6. Currently being considered for CABG surgery during the current hospitalisation following coronary angiography with plan to stop ticagrelor approximately 5 days before surgery
1. CABG surgery planned to occur urgently either less than 3 days after cessation of ticagrelor or less than 5 days after cessation of ticagrelor without guidance by platelet function testing
2. Treatment within the last 7 days or planned treatment with any antiplatelet drug other than aspirin and ticagrelor (including prasugrel, clopidogrel, dipyridamole, cilostazol, or glycoprotein IIb/IIIa antagonists) except for a short course of a glycoprotein IIb/IIIa antagonist (tirofiban or eptifibatide) as bridging therapy in those discontinuing ticagrelor at least 3 days prior to scheduled CABG surgery
3. Current or planned treatment prior to CABG surgery with oral or parenteral anti-inflammatory/immunomodulatory drugs (oral corticosteroids; disease-modifying anti-rheumatic drugs, including methotrexate at any dose; immunosuppressants; chemotherapy drugs), oral anti-coagulant medications (warfarin, dabigatran, rivaroxaban, edoxaban, apixaban) or intravenous fibrinolytic agents
4. Current or planned treatment prior to CABG surgery with a non-steroidal anti-inflammatory drug other than aspirin
5. Known hypersensitivity to or intolerance of aspirin, salicylic acid (including certain asthma patients who may suffer an asthma attack or faint), ticagrelor or excipients
6. Clinically significant liver disease, defined as a known or suspected diagnosis of hepatic cirrhosis with current Child-Pugh class B or C; or elevation of serum alanine transferase or aspartate transferase greater than 3 times the upper limit of the normal range for the processing laboratory on blood tests performed during the current hospitalisation
7. Abnormal full blood count on blood tests performed during the current hospitalisation that, in the opinion of the investigator, would preclude safe involvement in the study or compromise its scientific credibility
8. Evidence of active pathological bleeding
9. Participants with clinically significant co-morbidity that, in the opinion of the investigator, would preclude safe involvement in the study or compromise its scientific credibility
10. Any clinically significant abnormal laboratory test results during the current hospitalisation that, in the opinion of the investigator, would preclude safe involvement in the study
11. Pregnant or breastfeeding women
12. Known haemorrhagic diathesis or coagulation disorders such as haemophilia or moderate or severe thrombocytopenia (platelet count < 100 x 10 9/L)
13. Current treatment with a strong CYP3A inhibitor or inducer
14. Current treatment with doses of simvastatin or lovastatin >40 mg/day or CYP3A substrates with a narrow therapeutic index
15. Any other contraindication for ticagrelor or aspirin treatment as detailed in the respective SmPCs
16. Women of child-bearing potential (WOCBP) unless negative pregnancy test at screening and willing to use highly-effective contraception for the duration of treatment with study medication
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method