Status:
UNKNOWN
Maintenance Of aNtiplatElet Therapy in Patients With Coronary Stenting Undergoing Surgery (MONET BRIDGE)
Lead Sponsor:
Ospedale Santa Croce-Carle Cuneo
Conditions:
Platelet Aggregation Inhibitors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The MONET BRIDGE study is designed to assess the use of cangrelor as a platelet-inhibiting bridge for patients who discontinue DAPT before cardiac and non cardiac surgery within 12 months from coronar...
Detailed Description
This will be a randomized, double-blind, placebo-controlled study enrolling patients with coronary stent, still on DAPT, undergoing cardiac and non cardiac surgery within 12 months from coronary stent...
Eligibility Criteria
Inclusion
- Provide written informed consent before initiation of any study related procedures.
- Be ≥ 18 years of age.
- Have received any dose of a P2Y12 inhibitor (clopidogrel, ticlopidine, prasugrel, or ticagrelor) at any dose within at least 48 hours prior to randomization.
- Patients undergoing non deferrable cardiac or non cardiac surgery which requires discontinuation of P2Y12 inhibitor due to a significant bleeding risk.
Exclusion
- Confirmed of suspected pregnancy (if woman of child-bearing potential) or lactating females
- Active bleeding with evident contraindications to DAPT
- Patients requiring oral anticoagulant therapy
- PCI within 1 month
- Intracranial neoplasm or history of intracranial surgery
- History of bleeding diathesis
- Thrombocytopenia (platelet count of less than 100,000/µL)
- Known International Normalized Ratio (INR) greater than 1.5 at screening.
- Requirement for dialysis treatment (hemodialysis or peritoneal)
- Estimated Glomeular filtration rate eGFR \<30 ml/min
- Administration of abciximab within 24 hours of randomization or administration of eptifibitide or tirofiban within 12 hours of randomization
- Plans to continue oral anticoagulant or P2Y12 inhibitors or cangrelor in the pre-operative period
- Refusal to receive blood transfusion
- Receipt of fibrinolytic therapy in the 12 hours preceding randomization
- Allergy, hypersensitivity, or contraindication to cangrelor, mannitol, sorbitol, or microcrystalline cellulose
- High likelihood of being unavailable for follow-up
- Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within 30 days of randomization
- Any disease or condition which, in the judgment of the investigator, would place the patient at undue risk by being enrolled in the trial
Key Trial Info
Start Date :
June 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2021
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03862651
Start Date
June 1 2019
End Date
January 1 2021
Last Update
March 5 2019
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