The Randomized OPTIMAL-ACT Trial

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

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 Overview

• Status: Completed
• Conditions: Coronary Artery Disease; Ischemic Heart Disease; Anticoagulant-induced Bleeding; Coronary Syndrome
• Intervention / Treatment: Drug: Unfractionated heparin

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Shahyar M Gharacholou, MD, MSc, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2019
• Primary Completion (Actual): October 25, 2021
• Study Completion (Actual): October 25, 2021

Study Registration Dates

• First Submitted: December 8, 2018
• First Submitted That Met QC Criteria: December 10, 2018
• First Posted (Actual): December 11, 2018

Study Record Updates

• Last Update Posted (Actual): April 4, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: bleeding; outcomes; activated clotting time
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Calcium heparin
• Other Study ID Numbers: 18-005209

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No