Status:
COMPLETED
The Randomized OPTIMAL-ACT Trial
Lead Sponsor:
Mayo Clinic
Conditions:
Coronary Artery Disease
Ischemic Heart Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 medic...
Eligibility Criteria
Inclusion
- Age\>18
- Referred for coronary angiography with possible coronary revascularization or adjunctive invasive diagnostic testing (IVUS/OCT, FFR, or iFR)
Exclusion
- 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)
Key Trial Info
Start Date :
February 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 25 2021
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT03772613
Start Date
February 8 2019
End Date
October 25 2021
Last Update
April 4 2023
Active Locations (1)
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1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224