SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


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

1 3 4

Name: Vitamin-K antagonist at INR 2-3

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

Type: Drug

5

Name: AZD0837

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

Type: Drug

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:
Atrial fibrillation
Genes 70
SCN4B ANK2 RYR2 LMNA PRKAG2 MYPN SCN5A TNNT2 TNNI3K TNNI3 AGPAT2 CACNA2D1 HCN4 TTN POLG2 KCNE2 KCNQ1 SGO1 FOS MYOZ2 MYH7 LMNA CAVIN1 SCN2B PLN TNNC1 MFAP5 PRKAG2 TRDN TLL1 POLG CAV1 TAB2 TMEM43 ABCC9 SLC25A4 NKX2-5 ACTN2 XK TWNK KCNJ2 DTNA RRM2B KCNJ5 CACNB2 GJA5 FLNC TBX5 SCN5A BSCL2 CSRP3 KCNA5 CACNA1C MYL4 NEXN GATAD1 DMPK KCNQ1 NPPA PPARG KCNJ2 CAVIN1 GATA5 KCNQ1 SMAD3 CASQ2 KCNH2 NUP155 SCN1B SMAD3
Paroxysmal atrial fibrillation
Genes 12
KCNJ5 SCN5A CSRP3 KCNA5 KCNJ2 SCN2B MYL4 ABCC9 TBX5 KCNE2 SCN1B PRKAG2