Phase 2
Completed N=180
The Randomized OPTIMAL-ACT Trial
Coronary Artery Disease · Heart Failure · Anticoagulant-induced Bleeding · Coronary Syndrome
Source: ClinicalTrials.gov NCT03772613 ↗
Enrolled (actual)
180
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcomePrimary: Bleeding — 14; 15; 15 Participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bleeding |
14; 15; 15 | — |
| PRIMARY Adverse Clinical Events |
2; 0; 2 | — |
| SECONDARY Stent Thrombosis |
1; 0; 0 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT03772613). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.