Back to resultsThe Randomized OPTIMAL-ACT Trial
Primary Purpose
Coronary Artery Disease, Ischemic Heart Disease, Anticoagulant-induced Bleeding
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Unfractionated heparin
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring activated clotting time, outcomes, bleeding
Eligibility Criteria
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)
Sites / Locations
- Mayo Clinic in Florida
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Low ACT Target
Medium ACT Target
High ACT Target
Arm Description
ACT target range of 225 to 275 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used
ACT target range of 275 to 325 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used
ACT target range of 325 to 375 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used
Outcomes
Primary Outcome Measures
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)
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
Secondary Outcome Measures
Stent Thrombosis
Number of subjects to experience stent thrombosis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03772613
Brief Title
The Randomized OPTIMAL-ACT Trial
Official Title
Optimal Target of Activated Clotting Time During Percutaneous Coronary Intervention and Outcomes: The Randomized OPTIMAL-ACT Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 8, 2019 (Actual)
Primary Completion Date
October 25, 2021 (Actual)
Study Completion Date
October 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Ischemic Heart Disease, Anticoagulant-induced Bleeding, Coronary Syndrome
Keywords
activated clotting time, outcomes, bleeding
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low ACT Target
Arm Type
Active Comparator
Arm Description
ACT target range of 225 to 275 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used
Arm Title
Medium ACT Target
Arm Type
Active Comparator
Arm Description
ACT target range of 275 to 325 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used
Arm Title
High ACT Target
Arm Type
Active Comparator
Arm Description
ACT target range of 325 to 375 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used
Intervention Type
Drug
Intervention Name(s)
Unfractionated heparin
Intervention Description
Administration of unfractionated heparin will be assessed using the activated clotting time
Primary Outcome Measure Information:
Title
Bleeding
Description
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
Title
Adverse Clinical Events
Description
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 Outcome Measure Information:
Title
Stent Thrombosis
Description
Number of subjects to experience stent thrombosis
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahyar M Gharacholou, MD, MSc
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
The Randomized OPTIMAL-ACT Trial
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