The Randomized OPTIMAL-ACT Trial

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Despite the widespread adoption of recommended anticoagulation intensity ranges during percutaneous coronary intervention (PCI), there are limited randomized clinical trials testing specific targets for activated clotting times (ACT). The primary research hypothesis is that in the modern cardiac catheterization laboratory, where PCI procedural duration is relatively short, radial access with small caliber equipment is preferable, and where rates of intracoronary stenting and dual antiplatelet therapy use is high, lower ACT targets, as compared with higher ACT targets, will be associated with lower rates of bleeding while having similar rates of ischemic events.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Calcium heparin; Heparin

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)