The Randomized OPTIMAL-ACT Trial (NCT03772613) | Clinical Trial Compass
CompletedPhase 2
The Randomized OPTIMAL-ACT Trial
United States180 participantsStarted 2019-02-08
Plain-language 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 medical outcomes
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 ā„30 min OR support to maintain SBP ā„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)
What they're measuring
1
Bleeding
Timeframe: From date of randomization until the date of first documented bleeding event up to 24 hours