The Randomized OPTIMAL-ACT Trial

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Ischemic Heart Disease; Coronary Artery Disease; Coronary Syndrome; Anticoagulant-induced Bleeding

Treatments: Drug: Unfractionated heparin

Study type: Interventional

Funder types: Other

Identifiers

NCT03772613

18-005209

Details and patient eligibility

About

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

Enrollment: 180 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 3 patient groups

Low ACT Target

Active Comparator group

Description:

ACT target range of 225 to 275 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used

Treatment:

Drug: Unfractionated heparin

Medium ACT Target

Active Comparator group

Description:

ACT target range of 275 to 325 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used

Treatment:

Drug: Unfractionated heparin

High ACT Target

Active Comparator group

Description:

ACT target range of 325 to 375 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used

Treatment:

Drug: Unfractionated heparin