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Completed

NCT Number: NCT03772613

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

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Key information

Conditions

Coronary Artery Disease Angina Pectoris Angina, Unstable Anticoagulant-induced Bleeding Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Chest Pain Coronary Disease Coronary Syndrome Heart Diseases Hemorrhage Ischemic Heart Disease Myocardial Ischemia Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Unfractionated heparin

Drug

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

Primary outcomes

  1. Bleeding

    Time frame: From date of randomization until the date of first documented bleeding event up to 24 hours

    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)

  2. Adverse Clinical Events

    Time frame: 30 days

    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 outcomes

  1. Stent Thrombosis

    Time frame: 30 days

    Number of subjects to experience stent thrombosis

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 11, 2018
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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