The Randomized OPTIMAL-ACT Trial

Phase 2

Completed

• Conditions: Ischemic Heart Disease; Coronary Syndrome; Anticoagulant-induced Bleeding; Coronary Artery Disease
• Interventions: Drug: Unfractionated heparin

• Registration Number: NCT03772613
• Lead Sponsor: Mayo Clinic

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 medical outcomes

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-08
• Study First Submitted QC: 2018-12-10
• Study First Posted: 2018-12-11
• Study Start: 2019-02-08
• Primary Completion: 2021-10-25
• Study Completion: 2021-10-25
• Status Verified: 2023-03
• Results First Submitted: 2023-03-08
• Results First Submitted QC: 2023-03-08
• Last Update Submitted: 2023-03-08
• Results First Posted: 2023-04-04
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Age>18
• Referred for coronary angiography with possible coronary revascularization or adjunctive invasive diagnostic testing (IVUS/OCT, FFR, or iFR)

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High ACT Target	Unfractionated heparin	ACT target range of 325 to 375 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used
Medium ACT Target	Unfractionated heparin	ACT target range of 275 to 325 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used
Low ACT Target	Unfractionated heparin	ACT target range of 225 to 275 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used

Primary Outcome Measures

Name	Time	Method
Bleeding	From date of randomization until the date of first documented bleeding event up to 24 hours	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)
Adverse Clinical Events	30 days	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

Secondary Outcome Measures

Name	Time	Method
Stent Thrombosis	30 days	Number of subjects to experience stent thrombosis

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States