Anticoagulant-induced Bleeding, Coronary Artery Disease, Coronary Syndrome, Ischemic Heart Disease
Conditions
Keywords
activated clotting time, outcomes, bleeding
Brief 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
Interventions
DRUGUnfractionated heparin
Administration of unfractionated heparin will be assessed using the activated clotting time
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stent Thrombosis | 30 days | Number of subjects to experience stent thrombosis |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 61 |
| 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 | 61 |
| 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 | 58 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Medium ACT Target | High ACT Target | Total | Low ACT Target |
|---|---|---|---|---|
| Age, Continuous | 68 years STANDARD_DEVIATION 10 | 67 years STANDARD_DEVIATION 10 | 67 years STANDARD_DEVIATION 11 | 66 years STANDARD_DEVIATION 12 |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment United States | 61 participants | 58 participants | 180 participants | 61 participants |
| Sex: Female, Male Female | 18 Participants | 14 Participants | 51 Participants | 19 Participants |
| Sex: Female, Male Male | 43 Participants | 44 Participants | 129 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 61 | 0 / 58 |
| other Total, other adverse events | 4 / 61 | 5 / 61 | 8 / 58 |
| serious Total, serious adverse events | 0 / 61 | 0 / 61 | 0 / 58 |
Outcome results
Primary
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
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low ACT Target | Adverse Clinical Events | 2 Participants |
| Medium ACT Target | Adverse Clinical Events | 0 Participants |
| High ACT Target | Adverse Clinical Events | 2 Participants |
Primary
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)
Time frame: From date of randomization until the date of first documented bleeding event up to 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low ACT Target | Bleeding | 14 Participants |
| Medium ACT Target | Bleeding | 15 Participants |
| High ACT Target | Bleeding | 15 Participants |
Secondary
Stent Thrombosis
Number of subjects to experience stent thrombosis
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low ACT Target | Stent Thrombosis | 1 Participants |
| Medium ACT Target | Stent Thrombosis | 0 Participants |
| High ACT Target | Stent Thrombosis | 0 Participants |