Prevention of Stroke and Systemic Embolic Events in Patients With Atrial Fibrillation

AstraZeneca1,084 enrolled

Overview

The main purpose of this study is to provide dose-guiding information by assessing the safety and tolerability of 4 different dosing regimens of an extended-release (ER) formulation of AZD0837 compared with well-controlled, dose-adjusted Vitamin-K antagonists (VKA) (aiming for an international normalized ratio (INR) 2.0 to 3.0) in patients with non-valvular atrial fibrillation (AF) with one or more additional risk factors for stroke.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

1,084

Conditions

Nonvalvular Atrial Fibrillation

Interventions

AZD0837DRUG

ER tablet, PO, once daily for a period of 3-9 months.

Vitamin-K antagonist at INR 2-3DRUG

Tablet, PO for a period of 3-9 months.

AZD0837DRUG

ER tablet, PO, twice daily for a period of 3-9 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Nonvalvular AF (NVAF) verified by at least two ECGs in the last year separated by at least one week. * Previous cerebral ischemic attack (stroke or TIA, \>30 days prior to randomization) * Previous systemic embolism. * Symptomatic congestive heart failure (CHF) * Impaired left ventricular systolic function * Diabetes mellitus * Hypertension requiring anti-hypertensive treatment. Exclusion Criteria: * AF secondary to reversible disorders, eg hyperthyroidism, drugs and pulmonary embolism * Known contraindication to VKA treatment * Presence of a valvular heart disease, mechanical heart valves, active endocarditis, left ventricular aneurysm or thrombus, atrial myxoma or any condition other than AF requiring chronic anticoagulation treatment * Conditions associated with increased risk of major bleeding for example: history of intracranial bleeding, history of bleeding gastrointestinal disorder or major surgical procedure or trauma two weeks prior to randomization

Outcomes

Primary Outcomes

Bleeding Events

Number of patients with a bleeding event while on study drug. Patients with multiple events are counted once

Time frame: 36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)

Creatinine

Change in Creatinine values from baseline to week 12 visit for patients while on study drug (week 12 visit-baseline)

Time frame: 12 weeks according to protocol.(baseline to week 12 visit)

Alanine Aminotransferase (ALAT)

Number of patients while on study drug with ALAT\>=3 times upper limit of normal.l

Time frame: 36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)

Bilirubin

Number of patients while on study drug with Bilirubin\>=2 times upper limit of normal

Time frame: 36 weeks according to protocol. For patients who discontinued treatment the time frame was <36 weeks. Mean number of weeks was 21 weeks (baseline to end of treatment visit)

Secondary Outcomes

D-Dimer

Change in D-Dimer values from enrolment to week 12 visit for VKA naïve patients while on study drug (week 12 visit-enrolment)

Time frame: 14 weeks according to protocol.(enrolment to week 12 visit)

Activated Partial Thromboplastin Time (APTT)

Change in Activated partial thromboplastin time (APTT) from baseline to week 12 visit for VKA naïve patients while on study drug (week 12 visit-baseline)

Time frame: 12 weeks according to protocol.(baseline to week 12 visit)

Data from ClinicalTrials.gov

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