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Clinical trial

Perioperative Antiplatelet Therapy in Patients With Drug-eluting Stent Undergoing Noncardiac Surgery

ID
Name
AMCCV2016-10
Description
The purpose of this study is to evaluate the safety and effectiveness of perioperative antiplatelet therapy in patients with drug-eluting stent undergoing non-cardiac surgery.
Trial arms
Trial start
2017-03-16
Estimated PCD
2024-05-30
Trial end
2024-12-31
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Aspirin only
Aspirin only during surgery
Arms:
Aspirin only
No antiplatelet therapy
No antiplatelet therapy will be during surgery
Arms:
No antiplatelet therapy
Size
1010
Primary endpoint
The event rate of composite event of all-cause death, stent thrombosis, myocardial infarction, and stroke
30 days
Eligibility criteria
Inclusion Criteria: * Planned non-cardiac surgery at least after 12 months of implantation of drug eluting stent * Low or intermediate risk level surgery * Written informed consent Exclusion Criteria: * Acute coronary syndrome within 1 month * Heart failure NYHA III to IV * Contraindication to Aspirin * On anticoagulant therapy * Emergent surgery * Cardiac surgery * High bleeding risk surgeries, e.g., Intra-cranial surgery, Intra-spinal surgery, Retinal surgery * Pregnancy or breast-feeding * Life expectancy less than 1year
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 1010, 'type': 'ACTUAL'}}
Updated at
2024-05-16

1 organization

2 products

1 indication

Organization
Jung-Min Ahn
Product
Aspirin
Indication
Antiplatelet Drugs
Product
No antiplatelet therapy