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The Randomized OPTIMAL-ACT Trial

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ClinicalTrials.gov Identifier: NCT03772613
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Shahyar M. Gharacholou, Mayo Clinic

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 8, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

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




Primary Outcome Measures :
  1. Primary Study Endpoint: Bleeding [ Time Frame: 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)

  2. Primary Safety Endpoint: Composite of Net Adverse Clinical Events (NACE) [ Time Frame: 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 :
  1. Stent Thrombosis [ Time Frame: From date of randomization until the date of first documented stent thrombosis, assessed up to 30 days. ]
    Count of individuals who experience stent thrombosis



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772613


Locations
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United States, Florida
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Michael Gharacholou, MD    904-953-2000    gharacholou.shahyar@mayo.edu   
Principal Investigator: Shahyar M Gharacholou         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Shahyar M Gharacholou, MD, MSc Mayo Clinic

Additional Information:
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Responsible Party: Shahyar M. Gharacholou, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03772613     History of Changes
Other Study ID Numbers: 18-005209
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019

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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
Keywords provided by Shahyar M. Gharacholou, Mayo Clinic:
activated clotting time
outcomes
bleeding
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Hemorrhage
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Heparin
Calcium heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action