A Study to Evaluate Optimal Target of Activated Clotting Time During Percutaneous Coronary Intervention and Outcomes

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Jacksonville, Florida: 18-005209
    • Rochester, Minnesota: 18-005209
    NCT ID: NCT03772613
    Sponsor Protocol Number: 18-005209

About this study

The purpose of this study is to test the hypothesis that lower ACT target ranges, as compared to higher target ranges, are associated with reduced rates of bleeding. 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria: 

  • Adults, age >18 years old.
  • Adult patients 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).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Shahyar Gharacholou, M.D.

Contact us for the latest status

Contact information:

Inna Abrea

(904)953-3855

Abrea.Inna@mayo.edu

Rochester, Minn.

Mayo Clinic principal investigator

Shahyar Gharacholou, M.D.

Contact us for the latest status

Contact information:

Shahyar Gharacholou M.D.

(904)953-7278

Gharacholou.Shahyar@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20453734

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