Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
180 participants
INTERVENTIONAL
2019-02-08
2021-10-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Low ACT Target
ACT target range of 225 to 275 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used
Unfractionated heparin
Administration of unfractionated heparin will be assessed using the activated clotting time
Medium ACT Target
ACT target range of 275 to 325 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used
Unfractionated heparin
Administration of unfractionated heparin will be assessed using the activated clotting time
High ACT Target
ACT target range of 325 to 375 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used
Unfractionated heparin
Administration of unfractionated heparin will be assessed using the activated clotting time
Interventions
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Unfractionated heparin
Administration of unfractionated heparin will be assessed using the activated clotting time
Eligibility Criteria
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Inclusion Criteria
* Referred for coronary angiography with possible coronary revascularization or adjunctive invasive diagnostic testing (IVUS/OCT, FFR, or iFR)
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Shahyar M. Gharacholou
Principal Investigator
Principal Investigators
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Shahyar M Gharacholou, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Florida
Jacksonville, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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18-005209
Identifier Type: -
Identifier Source: org_study_id
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