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Report for Clinical Trial NCT00684307

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Controlled, Randomized, Parallel, Multicentre Study to Assess Safety and Tolerability of the Oral Direct Thrombin Inhibitor AZD0837, Given as an Extended-release Formulation, in the Prevention of Stroke and Systemic Embolic Events in Patients With Atrial Fibrillation

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.

NCT00684307 Nonvalvular Atrial Fibrillation
MeSH:Atrial Fibrillation
HPO:Atrial fibrillation Paroxysmal atrial fibrillation

3 Interventions

Name: AZD0837

Description: ER tablet, PO, once daily for a period of 3-9 months.
Type: Drug
Group Labels: 3

1 3 4

Name: Vitamin-K antagonist at INR 2-3

Description: Tablet, PO for a period of 3-9 months.
Type: Drug
Group Labels: 1

5

Name: AZD0837

Description: ER tablet, PO, twice daily for a period of 3-9 months
Type: Drug
Group Labels: 1

2


Primary Outcomes

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

Measure: Bleeding Events

Time: 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)

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

Measure: Creatinine

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

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

Measure: Alanine Aminotransferase (ALAT)

Time: 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)

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

Measure: Bilirubin

Time: 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

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

Measure: D-Dimer

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

Description: 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)

Measure: Activated Partial Thromboplastin Time (APTT)

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

Description: Change in Ecarin clotting time (ECT) from baseline to week 12 visit for patients while on study drug (week 12 visit-baseline)

Measure: Ecarin Clotting Time (ECT)

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

Description: Assessment made on the week 12 visit

Measure: Plasma Concentration of AZD0837 (Prodrug)

Time: 12 weeks after baseline according to protocol

Description: Assessment made on the week 12 visit

Measure: Plasma Concentration of AR-H067637XX (Active Metabolite)

Time: 12 weeks after baseline according to protocol

Description: Oral clearance of AR-H067637XX in subgroup of patients with genotype TT for gene polymorphism ABCB1 C3435T

Measure: Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype TT

Time: 36 weeks according to protocol

Description: Oral clearance of AR-H067637XX in subgroup of patients with genotype TC for gene polymorphism ABCB1 C3435T

Measure: Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype TC

Time: 36 weeks according to protocol

Description: Oral clearance of AR-H067637XX in subgroup of patients with genotype CC for gene polymorphism ABCB1 C3435T

Measure: Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype CC

Time: 36 weeks according to protocol

Purpose: Prevention

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 C3435T

Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype TT. --- C3435T ---

Oral clearance of AR-H067637XX in subgroup of patients with genotype TT for gene polymorphism ABCB1 C3435T. --- C3435T ---

Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype TC. --- C3435T ---

Oral clearance of AR-H067637XX in subgroup of patients with genotype TC for gene polymorphism ABCB1 C3435T. --- C3435T ---

Oral Clearance (CL/F) of AR-H067637XX (Active Metabolite) for C3435T Genotype CC. --- C3435T ---

Oral clearance of AR-H067637XX in subgroup of patients with genotype CC for gene polymorphism ABCB1 C3435T. --- C3435T ---



HPO Nodes


HPO: