Coronary Artery Disease Clinical Trial
Official title:
Optimal Target of Activated Clotting Time During Percutaneous Coronary Intervention and Outcomes: The Randomized OPTIMAL-ACT Trial
Verified date | March 2023 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to find the ideal range of the activated clotting time (ACT) during percutaneous coronary intervention (PCI) that is associated with lowering the rate of undesirable medical outcomes
Status | Completed |
Enrollment | 180 |
Est. completion date | October 25, 2021 |
Est. primary completion date | October 25, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age>18 - Referred for coronary angiography with possible coronary revascularization or adjunctive invasive diagnostic testing (IVUS/OCT, FFR, or iFR) Exclusion Criteria: - Receipt of LMWH at treatment dose (not DVT prophylaxis dose) within 6 hours of coronary angiography - Prior GP IIb/IIIa use within the previous 72 hours - Use of warfarin (vitamin K antagonist) or direct oral anticoagulant - Patients on LMWH bridging strategy - PCI within prior 30 days - Planned use of bivalirudin as the procedural anticoagulant - Rotational atherectomy - Excimer laser coronary angioplasty - Chronic total occlusions - Patients with active bleeding disorders or bleeding diathesis - Patients with ST-segment elevation myocardial infarction - Patient with clinical evidence of cardiogenic shock (defined as SBP<90 mmHg for =30 min OR support to maintain SBP =90 mmHg AND evidence of end-organ hypoperfusion (urine output <30 mL/h or cool extremities) - Chronic kidney disease stage 4/5 (GFR 30 mL/min) |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Florida | Jacksonville | Florida |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bleeding | Number of subjects to experience bleeding defined as Bleeding Academic Research Consortium (BARC) 1, 2, 3 or 5 or EASY hematoma classification after transradial/ulnar procedures (I-V) | From date of randomization until the date of first documented bleeding event up to 24 hours | |
Primary | Adverse Clinical Events | Number of subjects to experience a Net Adverse Clinical Event (NACE) defined as all-cause mortality, myocardial infarction, stroke, target lesion revascularization, or major bleeding | 30 days | |
Secondary | Stent Thrombosis | Number of subjects to experience stent thrombosis | 30 days |
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