Trial Outcomes & Findings for Atrial Fibrillation (AF) Patients Not Taking Vitamin-K Antagonist (VKA) (NCT NCT00623779)
NCT ID: NCT00623779
Last Updated: 2012-03-23
Results Overview
The premature discontinuation of study or study drug due to any reason
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
128 participants
Primary outcome timeframe
28 week (randomisation visit to last follow up visit in study) according to protocols
Results posted on
2012-03-23
Participant Flow
The study population included male and female participants \>18 years of age with chronic non-valvular Atrial Fibrillation. The participants were recruited during the time period from 22 October 2007 to 21 October 2008 at medical clinics in Europe.
For participants treated with Vitamin K Antagonists (VKA) at the time of enrollment, VKA treatment was to be adjusted (and stopped before randomisation) to ensure that INR was below 2.0 at randomisation. If this was not achieved the participant was discontinued from the study.
Participant milestones
| Measure |
AZD0837 150 mg
AZD0837 150 mg
|
AZD0837 300 mg
AZD0837 300 mg
|
Standard Therapy
Standard Therapy
|
|---|---|---|---|
|
Overall Study
STARTED
|
41
|
42
|
45
|
|
Overall Study
COMPLETED
|
38
|
39
|
44
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
1
|
Reasons for withdrawal
| Measure |
AZD0837 150 mg
AZD0837 150 mg
|
AZD0837 300 mg
AZD0837 300 mg
|
Standard Therapy
Standard Therapy
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
0
|
|
Overall Study
Criteria from CSR
|
2
|
0
|
1
|
Baseline Characteristics
Atrial Fibrillation (AF) Patients Not Taking Vitamin-K Antagonist (VKA)
Baseline characteristics by cohort
| Measure |
AZD0837 150 mg
n=41 Participants
AZD0837 150 mg
|
AZD0837 300 mg
n=42 Participants
AZD0837 300 mg
|
Standard Therapy
n=45 Participants
Standard Therapy
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
72.5 Years
STANDARD_DEVIATION 8 • n=5 Participants
|
71.6 Years
STANDARD_DEVIATION 8.51 • n=7 Participants
|
68.8 Years
STANDARD_DEVIATION 9.36 • n=5 Participants
|
70 Years
STANDARD_DEVIATION 8.68 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
49 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 28 week (randomisation visit to last follow up visit in study) according to protocolsThe premature discontinuation of study or study drug due to any reason
Outcome measures
| Measure |
AZD0837 150 mg
n=41 Participants
AZD0837 150 mg
|
AZD0837 300 mg
n=42 Participants
AZD0837 300 mg
|
Standard Therapy
n=45 Participants
Standard Therapy
|
|---|---|---|---|
|
Premature Discontinuation of Study or Study Drug Due to Any Reason
|
4 Participants
|
6 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 24 weeks (randomisation visit to last treatment visit)The premature discontinuation of study drug due to any reason
Outcome measures
| Measure |
AZD0837 150 mg
n=41 Participants
AZD0837 150 mg
|
AZD0837 300 mg
n=42 Participants
AZD0837 300 mg
|
Standard Therapy
n=45 Participants
Standard Therapy
|
|---|---|---|---|
|
Premature Discontinuation of Study Drug Due to Any Reason
|
3 Participants
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 28 weeks (randomisation visit to last follow up visit)\|The premature discontinuation of study due to any reason
Outcome measures
| Measure |
AZD0837 150 mg
n=41 Participants
AZD0837 150 mg
|
AZD0837 300 mg
n=42 Participants
AZD0837 300 mg
|
Standard Therapy
n=45 Participants
Standard Therapy
|
|---|---|---|---|
|
Premature Discontinuation of Study Due to Any Reason
|
4 Participants
|
4 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 24 weeks (randomisation visit to last treatment visit) according to protocol\[(number of doses dispensed-number of doses returned)/number of days between visits\]\*100
Outcome measures
| Measure |
AZD0837 150 mg
n=41 Participants
AZD0837 150 mg
|
AZD0837 300 mg
n=39 Participants
AZD0837 300 mg
|
Standard Therapy
Standard Therapy
|
|---|---|---|---|
|
Compliance With Study Drug
|
96.95 Percentage
Standard Deviation 16.503
|
99.82 Percentage
Standard Deviation 11.383
|
—
|
PRIMARY outcome
Timeframe: 28 weeks (randomisation visit to last follow up visit) according to protocol(number of visits attended acroos the time of study divided by the number of expected visits according to the time of entry into study)\*100
Outcome measures
| Measure |
AZD0837 150 mg
n=41 Participants
AZD0837 150 mg
|
AZD0837 300 mg
n=42 Participants
AZD0837 300 mg
|
Standard Therapy
n=45 Participants
Standard Therapy
|
|---|---|---|---|
|
Compliance With Study Visits/Assessments
|
93.3 Percentage
Standard Deviation 15.01
|
95.6 Percentage
Standard Deviation 10.45
|
97.5 Percentage
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: 24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)Population: 41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
Number of patients with a bleeding event while on study drug. Patients with multiple bleeding events are counted once
Outcome measures
| Measure |
AZD0837 150 mg
n=41 Participants
AZD0837 150 mg
|
AZD0837 300 mg
n=41 Participants
AZD0837 300 mg
|
Standard Therapy
n=46 Participants
Standard Therapy
|
|---|---|---|---|
|
Bleeding Events
|
0 Participants
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 4 weeks according to protocol (randomisation visit to week 4 visit)Individual change in Creatinine level (umil/L) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)
Outcome measures
| Measure |
AZD0837 150 mg
n=37 Participants
AZD0837 150 mg
|
AZD0837 300 mg
n=40 Participants
AZD0837 300 mg
|
Standard Therapy
n=45 Participants
Standard Therapy
|
|---|---|---|---|
|
Change in Creatinine Level
|
6.2 umol/L
Standard Deviation 8.64
|
3.6 umol/L
Standard Deviation 13.21
|
2.6 umol/L
Standard Deviation 12.90
|
SECONDARY outcome
Timeframe: 24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)Population: 41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
Number of patients while on study drug with Alanine aminotransferase (ALAT)\>=3 times upper limit of normal.
Outcome measures
| Measure |
AZD0837 150 mg
n=41 Participants
AZD0837 150 mg
|
AZD0837 300 mg
n=41 Participants
AZD0837 300 mg
|
Standard Therapy
n=46 Participants
Standard Therapy
|
|---|---|---|---|
|
Alanine Aminotransferase (ALAT)
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 24 weeks (randomisation visit to last treatment visit) according to protocol. For patients who discontinued treatment the time frame was <24 weeks. Mean number of weeks was 7 weeks (baseline to end of treatment visit)Population: 41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
Number of patients while on study drug with Bilirubin\>=2 times upper limit of normal.
Outcome measures
| Measure |
AZD0837 150 mg
n=41 Participants
AZD0837 150 mg
|
AZD0837 300 mg
n=41 Participants
AZD0837 300 mg
|
Standard Therapy
n=46 Participants
Standard Therapy
|
|---|---|---|---|
|
Bilirubin
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 4 weeks after baseline according to protocolAssessment of plasma concentration of AZD0837 (prodrug) made on the week 4 visit
Outcome measures
| Measure |
AZD0837 150 mg
n=24 Participants
AZD0837 150 mg
|
AZD0837 300 mg
n=26 Participants
AZD0837 300 mg
|
Standard Therapy
Standard Therapy
|
|---|---|---|---|
|
Plasma Concentration of AZD0837 (Prodrug)
|
596.0 nmol/L
Interval 5.0 to 2920.0
|
636.0 nmol/L
Interval 18.2 to 5920.0
|
—
|
SECONDARY outcome
Timeframe: 4 weeks after baseline according to protocolAssessment of plasma concentration of AR-H067637XX (active metabolite) made on the week 4 visit
Outcome measures
| Measure |
AZD0837 150 mg
n=24 Participants
AZD0837 150 mg
|
AZD0837 300 mg
n=26 Participants
AZD0837 300 mg
|
Standard Therapy
Standard Therapy
|
|---|---|---|---|
|
Plasma Concentration of AR-H067637XX (Active Metabolite)
|
258.5 nmol/L
Interval 5.0 to 539.0
|
368.5 nmol/L
Interval 159.0 to 776.0
|
—
|
SECONDARY outcome
Timeframe: 4 weeks according to protocol.(baseline to week 4 visit)Individual change in D-Dimer level (ng/ml) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)
Outcome measures
| Measure |
AZD0837 150 mg
n=38 Participants
AZD0837 150 mg
|
AZD0837 300 mg
n=38 Participants
AZD0837 300 mg
|
Standard Therapy
n=43 Participants
Standard Therapy
|
|---|---|---|---|
|
Change in D-Dimer Level
|
-33.484 ng/ml
Interval -78.37 to 288.13
|
-41.445 ng/ml
Interval -92.61 to 130.0
|
4.853 ng/ml
Interval -80.12 to 793.56
|
SECONDARY outcome
Timeframe: 4 weeks according to protocol.(baseline to week 4 visit)Individual change in Activated partial thromboplastin time (APTT) (sec) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)
Outcome measures
| Measure |
AZD0837 150 mg
n=25 Participants
AZD0837 150 mg
|
AZD0837 300 mg
n=20 Participants
AZD0837 300 mg
|
Standard Therapy
Standard Therapy
|
|---|---|---|---|
|
Activated Partial Thromboplastin Time (APTT)
|
31.74 sec
Interval -17.8 to 105.8
|
51.51 sec
Interval 3.1 to 75.1
|
—
|
SECONDARY outcome
Timeframe: 4 weeks according to protocol.(baseline to week 4 visit)Individual change in Ecarin clotting time (ECT) (sec) from baseline to week 4 visit for patients while on study drug (week 4 visit-baseline)
Outcome measures
| Measure |
AZD0837 150 mg
n=24 Participants
AZD0837 150 mg
|
AZD0837 300 mg
n=18 Participants
AZD0837 300 mg
|
Standard Therapy
Standard Therapy
|
|---|---|---|---|
|
Ecarin Clotting Time (ECT)
|
125.6 sec
Interval 6.0 to 274.0
|
179.1 sec
Interval 7.0 to 341.0
|
—
|
Adverse Events
AZD0837 150 mg
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
AZD0837 300 mg
Serious events: 3 serious events
Other events: 1 other events
Deaths: 0 deaths
Standard Therapy
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD0837 150 mg
n=41 participants at risk
AZD0837 150 mg
|
AZD0837 300 mg
n=41 participants at risk
AZD0837 300 mg
|
Standard Therapy
n=46 participants at risk
Standard Therapy
|
|---|---|---|---|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/41
41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
|
2.4%
1/41
41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
|
0.00%
0/46
41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
0.00%
0/41
41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
|
0.00%
0/41
41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
|
2.2%
1/46
41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
|
|
General disorders
Drug Intolerance
|
0.00%
0/41
41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
|
2.4%
1/41
41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
|
0.00%
0/46
41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
|
|
Metabolism and nutrition disorders
Podagra
|
0.00%
0/41
41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
|
0.00%
0/41
41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
|
2.2%
1/46
41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
|
|
Renal and urinary disorders
Renal Failure
|
2.4%
1/41
41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
|
0.00%
0/41
41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
|
0.00%
0/46
41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
|
|
Vascular disorders
Hypotension
|
2.4%
1/41
41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
|
0.00%
0/41
41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
|
0.00%
0/46
41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/41
41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
|
2.4%
1/41
41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
|
0.00%
0/46
41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
|
Other adverse events
| Measure |
AZD0837 150 mg
n=41 participants at risk
AZD0837 150 mg
|
AZD0837 300 mg
n=41 participants at risk
AZD0837 300 mg
|
Standard Therapy
n=46 participants at risk
Standard Therapy
|
|---|---|---|---|
|
Infections and infestations
Bronchitis
|
7.3%
3/41
41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
|
2.4%
1/41
41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
|
2.2%
1/46
41 + 42 + 45 participants were randomized into the study to treatment arm 1, arm 2 and arm 3 respectively. However, one of the participants randomized to arm 2 was treated according to treatment arm 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60