The Randomized OPTIMAL-ACT Trial

Study Overview
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Brief Summary
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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

Official Title
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Optimal Target of Activated Clotting Time During Percutaneous Coronary Intervention and Outcomes: The Randomized OPTIMAL-ACT Trial

Conditions
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Coronary Artery Disease, Ischemic Heart Disease, Anticoagulant-induced Bleeding, Coronary Syndrome

Intervention / Treatment
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* Drug: Unfractionated heparin


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low ACT Target<br>ACT target range of 225 to 275 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used | Drug: Unfractionated heparin<br>* Administration of unfractionated heparin will be assessed using the activated clotting time<br>|
| Active Comparator: Medium ACT Target<br>ACT target range of 275 to 325 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used | Drug: Unfractionated heparin<br>* Administration of unfractionated heparin will be assessed using the activated clotting time<br>|
| Active Comparator: High ACT Target<br>ACT target range of 325 to 375 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used | Drug: Unfractionated heparin<br>* Administration of unfractionated heparin will be assessed using the activated clotting time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent Thrombosis | Number of subjects to experience stent thrombosis | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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activated clotting time, outcomes, bleeding