Stroke Reduction in Pacemaker Patients

Phase 1

• Conditions: Device-detected sub-clinical atrial fibrillation; 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: EUCTR2014-001397-33-GB
• Lead Sponsor: Hamilton Health Sciences Corporation through its Population Health Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-23
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 4000

Inclusion Criteria

1. Permanent pacemaker or defibrillator (with or without resynchronization) or insertable cardiac monitor capable of detecting SCAF
2. At least one episode of device-detected SCAF = 6 minutes in duration (atrial rate > 175/min if an atrial lead is present), but no single episode > 24 hours in duration at any time prior to enrollment. SCAF requires electrogram confirmation (at least one episode) unless = 6 hours in duration
3. Age = 55 years
4. Risk Factor(s) for Stroke:
Previous stroke, TIA or systemic arterial embolism
OR
Age at least 75
OR
Age 65-74 with at least 2 other risk factors
OR
Age 55-64 with at least 3 other risk factors

Other risk factors are:
• hypertension
• CHF
• diabetes
• vascular disease (i.e. CAD, PAD or Aortic Plaque)
• female

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2500

Exclusion Criteria

1.Clinical atrial fibrillation documented by surface ECG (12 lead ECG, Telemetry, Holter) lasting = 6 minutes, with or without clinical symptoms
2.Receiving treatment with an oral anticoagulant for any reason (i.e., Mechanical valve prosthesis, deep vein thrombosis, etc.)
3.Severe heart failure, not currently receiving adequate treatment
4.Allergy to aspirin or apixaban
5.Severe renal insufficiency (serum creatinine > 2.5 mg/dL [221 µmol/L] or a calculated creatinine clearance < 25 ml/min)
6.Serious bleeding in the last 6 months or at high risk of bleeding (this includes, but is not limited to: prior intracranial hemorrhage, active peptic ulcer disease, clinically significant thrombocytopenia or anemia, recent stroke within past 10 days, documented hemorrhagic tendencies or blood dyscrasias)
7.Moderate to severe hepatic impairment
8.Ongoing need for combination therapy with aspirin and clopidogrel (or other combination of two platelet inhibitors)
9.Meets criteria for requiring lower dose of apixaban AND also has ongoing need for strong inhibitors of both CYP3A4 and P-glycoprotein (e.g., ketoconazole, itraconazole, ritonavir or clarithromycin)
10.Ongoing need for strong inducers of both CYP3A4 and P-glycoprotein (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort)
11.Received an investigational drug in the past 30 days
12.Participants considered by the investigator to be unsuitable for the study for any of the following reasons:
a.Not agreeable for treatment with either aspirin or apixaban or anticipated to have poor compliance on study drug treatment
b.Unwilling to attend study follow-up visits
c.Life expectancy less than 2 years due to concomitant disease
13.Women who are pregnant, breast-feeding or of child-bearing potential without an acceptable form of contraception in place (sexual abstinence for duration of study treatment*, combined (estrogen & progestogen) or progestogen-only hormonal contraception , intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or other method with less than 1% failure rate)

*defined as refraining from heterosexual intercourse during the entire duration of study treatment. This must be evaluated in relationship to the expected duration of study treatment for each patient.

Study & Design

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