CompletedPhase 2

The Randomized OPTIMAL-ACT Trial

United States180 participantsStarted 2019-02-08

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Bleeding

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

Adverse Clinical Events

Timeframe: 30 days

Trial details

NCT IDNCT03772613

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-10-25

Results submitted2023-03-08

View on ClinicalTrials.gov More Coronary Artery Disease trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.