The Randomized OPTIMAL-ACT Trial

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03772613
• Other study ID #: 18-005209
• Status: Completed
• Phase: Phase 2
• Start date: February 8, 2019
• Est. completion date: October 25, 2021

Study information

• Verified date: March 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: October 25, 2021
• Est. primary completion date: October 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anticoagulant-induced Bleeding
• Coronary Artery Disease
• Coronary Syndrome
• Heart Diseases
• Hemorrhage
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Drug:
• Unfractionated heparin
Administration of unfractionated heparin will be assessed using the activated clotting time

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Stent Thrombosis	Number of subjects to experience stent thrombosis	30 days

External Links

•   Mayo Clinic Clinical Trials