The Randomized OPTIMAL-ACT Trial

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT03772613

Collaborator

(none)

546

Enrollment

Location

Arms

58.7

Anticipated Duration (Months)

9.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Despite the widespread adoption of recommended anticoagulation intensity ranges during percutaneous coronary intervention (PCI), there are limited randomized clinical trials testing specific targets for activated clotting times (ACT). The primary research hypothesis is that in the modern cardiac catheterization laboratory, where PCI procedural duration is relatively short, radial access with small caliber equipment is preferable, and where rates of intracoronary stenting and dual antiplatelet therapy use is high, lower ACT targets, as compared with higher ACT targets, will be associated with lower rates of bleeding while having similar rates of ischemic events.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Ischemic Heart Disease Anticoagulant-induced Bleeding Coronary Syndrome	Drug: Unfractionated heparin	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

546 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 8, 2019

Anticipated Primary Completion Date :

Jan 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Primary Study Endpoint: Bleeding [From date of randomization until the date of first documented bleeding event up to 24 hours]
Count of any individuals experiencing any of the following: Bleeding Academic Research Consortium (BARC) 1, 2, 3 or 5 or EASY hematoma classification after transradial/ulnar procedures (I-V)
Primary Safety Endpoint: Composite of Net Adverse Clinical Events (NACE) [From date of randomization until the date of first documented NACE event (all-cause mortality, myocardial infarction, stroke, target lesion revascularization, or major bleeding) , whichever came first, assessed up to 30 days.]
Count of individuals experiencing any of the following: all-cause mortality, myocardial infarction, stroke, target lesion revascularization, or major bleeding

Secondary Outcome Measures

Stent Thrombosis [From date of randomization until the date of first documented stent thrombosis, assessed up to 30 days.]
Count of individuals who experience stent thrombosis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)