Maintenance Of aNtiplatElet Therapy in patients with coronary stenting undergoing surgery

Phase 1

• Conditions: Patients a least 18 years of age on DAPT per standard of care who are planned to undergo non deferrable cardiac and non cardiac surgery which will require discontinuation of a P2Y12 inhibitor. Subjects with stent implantation within 12 months of an ACS and within 6 months of elective stent implantation for stable CAD, or subjects subjected to elective PCI within the previous 12 months if still in DAPT because considered high-risk thrombotic will be included.; MedDRA version: 20.0Level: HLGTClassification code 10011082Term: Coronary artery disordersSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-004446-42-IT
• Lead Sponsor: AZIENDA SANITARIA OSPEDALIERA S.CROCE E CARLE CUNEO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-21
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 140

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.
5. Female subject of potential child-bearing should have a negative pregnancy test (preferably serum hCG pregnancy test) at screening.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

1. Active bleeding with evident contraindications to DAPT
2. Patients requiring oral anticoagulant therapy
3. PCI within 1 month
4. Intracranial neoplasm or history of intracranial surgery
5. History of bleeding diathesis
6. Thrombocytopenia (platelet count of less than 100,000/µL)
7. Known International Normalized Ratio (INR) greater than 1.5 at screening.
8. Requirement for dialysis treatment (hemodialysis or peritoneal)
9. Estimated Glomeular filtration rate eGFR <30 ml/min
10. Administration of abciximab within 24 hours of randomization or administration of eptifibitide or tirofiban within 12 hours of randomization
11. Plans to continue oral anticoagulant or P2Y12 inhibitors or cangrelor in the pre-operative period
12. Refusal to receive blood transfusion
13. Receipt of fibrinolytic therapy in the 12 hours preceding randomization
14. Allergy, hypersensitivity, or contraindication to cangrelor, mannitol, sorbitol, or microcrystalline cellulose
15. High likelihood of being unavailable for follow-up
16. Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of randomization
17. Confirmed of suspected pregnancy (if woman of child-bearing potential) or lactating females confirmed. Pregnancy status must be confirmed by serum or urine test (preferably by a serum hCG pregnancy test)
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified