Trial Outcomes & Findings for D-Dimer Determined Anticoagulation INTENSITY in Patients With Mechanical Valve Replacement (NCT NCT01996657)
NCT ID: NCT01996657
Last Updated: 2017-06-26
Results Overview
The bleeding events included cerebral hemorrhage, gastrointestinal bleeding and other major internal or external bleeding that causes death, hospitalization, or permanent injury (e.g. vision loss) or necessitates transfusion.
Recruitment status
COMPLETED
Target enrollment
772 participants
Primary outcome timeframe
Up to 24 months
Results posted on
2017-06-26
Participant Flow
Participant milestones
| Measure |
Standard Intensity of Anticoagulation
After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).
Warfarin
|
Low Intensity and Adjusted by Elevated D-dimer
The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.
Warfarin
|
Low Intensity Without Adjustment
The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),
Warfarin
|
|---|---|---|---|
|
Overall Study
STARTED
|
250
|
250
|
248
|
|
Overall Study
COMPLETED
|
237
|
239
|
234
|
|
Overall Study
NOT COMPLETED
|
13
|
11
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
D-Dimer Determined Anticoagulation INTENSITY in Patients With Mechanical Valve Replacement
Baseline characteristics by cohort
| Measure |
Standard Intensity of Anticoagulation
n=237 Participants
After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).
Warfarin
|
Low Intensity and Adjusted by Elevated D-dimer
n=239 Participants
The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.
Warfarin
|
Low Intensity Without Adjustment
n=234 Participants
The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),
Warfarin
|
Total
n=710 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48.8 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
50.4 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
50.1 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
49.8 years
STANDARD_DEVIATION 11.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
113 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
311 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
124 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
399 Participants
n=4 Participants
|
|
Elevated D-dimer(n)
|
17 participants
n=5 Participants
|
36 participants
n=7 Participants
|
38 participants
n=5 Participants
|
91 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 24 monthsThe bleeding events included cerebral hemorrhage, gastrointestinal bleeding and other major internal or external bleeding that causes death, hospitalization, or permanent injury (e.g. vision loss) or necessitates transfusion.
Outcome measures
| Measure |
Standard Intensity of Anticoagulation
n=237 Participants
After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).
Warfarin
|
Low Intensity and Adjusted by Elevated D-dimer
n=239 Participants
The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.
Warfarin
|
Low Intensity Without Adjustment
n=234 Participants
The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),
Warfarin
|
|---|---|---|---|
|
Bleeding Events;
|
16 Participants
|
3 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 24 monthsThe thrombotic events included valve thrombosis, transient ischemic attack, ischemic stroke, peripheral embolism, and myocardial infarction.
Outcome measures
| Measure |
Standard Intensity of Anticoagulation
n=237 Participants
After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).
Warfarin
|
Low Intensity and Adjusted by Elevated D-dimer
n=239 Participants
The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.
Warfarin
|
Low Intensity Without Adjustment
n=234 Participants
The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),
Warfarin
|
|---|---|---|---|
|
Thrombotic Events
|
5 Participants
|
5 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to 24 monthsThe deaths from all causes
Outcome measures
| Measure |
Standard Intensity of Anticoagulation
n=237 Participants
After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).
Warfarin
|
Low Intensity and Adjusted by Elevated D-dimer
n=239 Participants
The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.
Warfarin
|
Low Intensity Without Adjustment
n=234 Participants
The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),
Warfarin
|
|---|---|---|---|
|
All Cause Deaths
|
12 Participants
|
4 Participants
|
5 Participants
|
Adverse Events
Standard Intensity of Anticoagulation
Serious events: 24 serious events
Other events: 0 other events
Deaths: 12 deaths
D-dimer-guided Adjustmentd of Anticoagutlation Intensity
Serious events: 9 serious events
Other events: 0 other events
Deaths: 4 deaths
Low Intensity Without Adjustment
Serious events: 20 serious events
Other events: 0 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Standard Intensity of Anticoagulation
n=245 participants at risk
After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).
Warfarin
|
D-dimer-guided Adjustmentd of Anticoagutlation Intensity
n=245 participants at risk
The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.
Warfarin
|
Low Intensity Without Adjustment
n=242 participants at risk
The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),
Warfarin
|
|---|---|---|---|
|
Blood and lymphatic system disorders
thrombotic envents
|
2.0%
5/245
|
2.0%
5/245
|
5.8%
14/242
|
|
Blood and lymphatic system disorders
bleeding events
|
6.5%
16/245
|
1.2%
3/245
|
1.7%
4/242
|
|
Cardiac disorders
Deaths from other causes
|
1.2%
3/245
|
0.41%
1/245
|
0.83%
2/242
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place