The Randomized OPTIMAL-ACT Trial

Mayo Clinic180 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

180

Conditions

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

Interventions

Unfractionated heparinDRUG

Administration of unfractionated heparin will be assessed using the activated clotting time

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Mayo Clinic in Florida

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

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)

Time frame: 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

Time frame: 30 days

Secondary Outcomes

Stent Thrombosis

Number of subjects to experience stent thrombosis

Time frame: 30 days

Data from ClinicalTrials.gov

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