Coronary Artery DiseasePhase 2NCT03772613
The Randomized OPTIMAL-ACT Trial
A Phase 2 study testing Unfractionated heparin in people with Coronary Artery Disease and Ischemic Heart Disease, run by Mayo Clinic at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Ischemic Heart Disease, Anticoagulant-induced Bleeding
- What is being tested?
- Unfractionated heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2019to 25 Oct 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18
- Referred for coronary angiography with possible coronary revascularization or adjunctive invasive diagnostic testing (IVUS/OCT, FFR, or iFR)
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal Target of Activated Clotting Time During Percutaneous Coronary Intervention and Outcomes: 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
- Conditions
- Coronary Artery Disease, Ischemic Heart Disease, Anticoagulant-induced Bleeding, Coronary Syndrome
- Being tested
- Unfractionated heparin
- Keywords
- activated clotting time, outcomes, bleeding
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia, Angina, Unstable, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unfractionated heparinDrug
Administration of unfractionated heparin will be assessed using the activated clotting time
| Study group | Role | What they receive |
|---|---|---|
| Low ACT Target | Active comparator | ACT target range of 225 to 275 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Receives: Drug: Unfractionated heparin |
| Medium ACT Target | Active comparator | ACT target range of 275 to 325 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Receives: Drug: Unfractionated heparin |
| High ACT Target | Active comparator | ACT target range of 325 to 375 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Receives: Drug: Unfractionated heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding
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)
Measured: From date of randomization until the date of first documented bleeding event up to 24 hours
Adverse Clinical Events
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
Measured: 30 days
Secondary outcomes (1)
Stent Thrombosis
Number of subjects to experience stent thrombosis
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start8 Feb 2019
- Primary completion25 Oct 2021
- Study completion25 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahyar M. Gharacholou, Mayo Clinic
- Investigators
- Shahyar M Gharacholou, MD, MSc, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772613
- Sponsor's protocol ID
- 18-005209
- Status last verified
- Mar 2023
- First submitted
- 8 Dec 2018
- Last updated
- 4 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Target of Activated Clotting Time During Percutaneous Coronary Intervention and Outcomes: The Randomized OPTIMAL-ACT Trial
- ClinicalTrials.gov ID
- NCT03772613
- Acronym / sponsor ID
- 18-005209
- Conditions
- Coronary Artery Disease, Ischemic Heart Disease, Anticoagulant-induced Bleeding, Coronary Syndrome
- Keywords
- activated clotting time, outcomes, bleeding
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 11 Dec 2018 (actual)
- Results
- Posted 4 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low ACT Target | Active comparator | Drug: Unfractionated heparinACT target range of 225 to 275 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used |
| Medium ACT Target | Active comparator | Drug: Unfractionated heparinACT target range of 275 to 325 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used |
| High ACT Target | Active comparator | Drug: Unfractionated heparinACT target range of 325 to 375 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age>18
- Referred for coronary angiography with possible coronary revascularization or adjunctive invasive diagnostic testing (IVUS/OCT, FFR, or iFR)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unfractionated heparinAdministration of unfractionated heparin will be assessed using the activated clotting time | Drug | High ACT Target, Low ACT Target, Medium ACT Target |
Primary outcome
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)
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
1 secondary outcome
Stent Thrombosis
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shahyar M Gharacholou, MD, MSc principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Unfractionated heparin in people with Coronary Artery Disease and Ischemic Heart Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bleeding (time frame: From date of randomization until the date of first documented bleeding event up to 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2023.