EDOXABAN TREATMENT VERSUS VKA IN PATIENTS WITH AF UNDERGOING PCI.

Phase 1

• Conditions: MedDRA version: 20.0 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-002683-14-PT
• Lead Sponsor: Daiichi Sankyo Europe GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-23
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1500

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 patientes =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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 700
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 800

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.End stage renal disease (ESRD) (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; intr

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified