Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT03862651
Eligibility Criteria:
Inclusion Criteria:
1. Provide written informed consent before initiation of any study related procedures.
2. Be ≥ 18 years of age.
3. Have received any dose of a P2Y12 inhibitor (clopidogrel, ticlopidine, prasugrel, or ticagrelor) at any dose within at least 48 hours prior to randomization.
4. Patients undergoing non deferrable cardiac or non cardiac surgery which requires discontinuation of P2Y12 inhibitor due to a significant bleeding risk.
Exclusion Criteria:
1. Confirmed of suspected pregnancy (if woman of child-bearing potential) or lactating females
2. Active bleeding with evident contraindications to DAPT
3. Patients requiring oral anticoagulant therapy
4. PCI within 1 month
5. Intracranial neoplasm or history of intracranial surgery
6. History of bleeding diathesis
7. Thrombocytopenia (platelet count of less than 100,000/µL)
8. Known International Normalized Ratio (INR) greater than 1.5 at screening.
9. Requirement for dialysis treatment (hemodialysis or peritoneal)
10. Estimated Glomeular filtration rate eGFR \<30 ml/min
11. Administration of abciximab within 24 hours of randomization or administration of eptifibitide or tirofiban within 12 hours of randomization
12. Plans to continue oral anticoagulant or P2Y12 inhibitors or cangrelor in the pre-operative period
13. Refusal to receive blood transfusion
14. Receipt of fibrinolytic therapy in the 12 hours preceding randomization
15. Allergy, hypersensitivity, or contraindication to cangrelor, mannitol, sorbitol, or microcrystalline cellulose
16. High likelihood of being unavailable for follow-up
17. Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of randomization
18. Any disease or condition which, in the judgment of the investigator, would place the patient at undue risk by being enrolled in the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03862651
Study Brief:
Protocol Section:
NCT03862651