Evaluation of the safety and efficacy of an edoxaban-based compared to a vitamin K antagonist- based antithrombotic regimen following successful percutaneous coronary intervention (PCI) with stent placement (ENTRUST_AF PCI)

Phase 3

Completed

• Conditions: 10014523; Thrombosis after a percutaneous coronary intervention with stent placement; Thrombosis after angioplasty with stent placement; 10007521

• Registration Number: NL-OMON46857
• Lead Sponsor: Daiichi Pharmaceutical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 38

Inclusion Criteria

1.OAC indication for atrial fibrillation for a period of at least 12 months following successful PCI with stenting in adult male and female patients *18 years of age. Eligibility is assessed 4 hours after sheath removal and within 5 days after successful PCI with stent placement. If a staged PCI is planned, eligibility is assessed after completion of the last stage.;Successful PCI definition:
The success of a PCI procedure is defined by 2 interrelated components:
angiographic findings, procedural / clinical outcomes as detailed below:
- Angiographic Success
- A minimum stenosis diameter of < 20% (as visually assessed by
angiography - residual blockage or stenosis reduced to less than 20% of
the artery's diameter).
- Sufficient enlargement of the lumen at the target site to improve
coronary artery blood flow with final TIMI flow grade 3 (visually
assessed by angiography), without occlusion of a significant side branch,
flow-limiting dissection, distal embolization, or angiographic thrombus.;Procedural Success:
No major in-hospital clinical complications(e.g. ongoing ISTH, major or
clinical relevant non-major procedural bleeding at the time of
randomization, stroke, emergency CABG).;In summary, a clinically successful PCI requires both anatomic and
procedural success along with relief of signs and/or symptoms of
myocardial ischemia at the time of randomization.

Exclusion Criteria

Bleeding risks or systemic conditions
1.Known bleeding diathesis, including but not limited to,
a.Uncontrolled active bleeding, encompassing both ISTH major and
clinically relevant non-major bleeding, preceding randomization.
b.Lesion or condition, if considered to be a significant risk for major
bleeding.
This may include but is not limited to: unresolved gastrointestinal
ulceration, presence of malignant neoplasms at high risk of bleeding
(e.g. malignancies with metastasis), recent unresolved brain or spinal
injury, recent brain, spinal or ophthalmic surgery, any intracranial
hemorrhage, known or suspected esophageal varices, arteriovenous
malformations, vascular aneurysms (of more than 3.5 cm) or major
intraspinal or intracerebral vascular abnormalities.;Medication-related
2.INR > 2.5 (the subject can be reconsidered at a later time, but within 5
days of sheath removal).
3.Contraindication to edoxaban, VKA, ASA and/or P2Y12 antagonists;
4.Concomitant treatment with other antithrombotic agents, fibrinolytic
therapy and chronic nonsteroidal anti-inflammatory drugs (NSAIDs).;Concomitant conditions and therapies
5. Critically ill or hemodynamically unstable subjects (at the time of
randomization) including:
a.cardiogenic shock or acute decompensated heart failure, with the
requirement for vasopressor agents or inotropic support or mechanical
support to support circulation
b.respiratory failure requiring endotracheal intubation and mechanical
ventilation.
6.Any prior mechanical valvular prosthesis;
7.Planned coronary or vascular intervention or major surgery within 12
months; Randomization must be deferred to the last stage in a multistep,
multivessel PCI procedure;
8.Moderate or severe mitral stenosis;
9.Ischemic stroke within 2 weeks prior to randomization;
10.Uncontrolled severe hypertension with a systolic blood pressure (BP)
*180 mmHg and/or diastolic BP * 120 mmHg;
11.Severe renal impairment with estimated creatinine clearance (CrCL)
< 15 mL/min or on dialysis;
12.Known abnormal liver function prior to randomization (incl. hepatic
disease or biochemical evidence of significant liver derangement known
prior to randomization;Other exclusion criteria
13.Any of the following abnormal local laboratory results prior to
randomization:
a.Platelet count < 50 x109/L
b.Hemoglobin < 8 mg/dL
14.Unable to provide written IC;
15.Female subjects of childbearing potential without using highly effective contraception (female of childbearing potential is defined as one who has not been postmenopausal for at least one year, or has not been surgically sterilised, or has not had a hysterectomy at least three months prior to the start of this study). Females taking oral contraceptives should have been on therapy for at least three months. Adequate contraceptives include: Combined (estrogen and progestogen
containing) oral, intravaginal, transdermal, hormonal contraception associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; sexual abstinence);
16.Pregnant or breast-feeding subjects;
17.Assessment that the subject is not likely to comply with the study
procedures or have complete follow-up;
18.Participating in another clinical trial that potentially interfer

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the composite of major or clinically relevant non-major<br /><br>bleeding (MCRB) defined according to the ISTH bleeding definitions, analyzed as<br /><br>time to first occurrence of any component.</p><br>