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Trial record 23 of 293 for:    warfarin AND anticoagulation

D-Dimer Determined Anticoagulation INTENSITY in Patients With Mechanical Valve Replacement (3D-INTENSITY)

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ClinicalTrials.gov Identifier: NCT01996657
Recruitment Status : Completed
First Posted : November 27, 2013
Results First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Sponsor:
Information provided by (Responsible Party):
Wuhan Asia Heart Hospital

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Heart Valve Disease
Intervention Drug: Warfarin
Enrollment 772
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Standard Intensity of Anticoagulation Low Intensity and Adjusted by Elevated D-dimer Low Intensity Without Adjustment
Hide Arm/Group Description

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

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

The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),

Warfarin

Period Title: Overall Study
Started 250 250 248
Completed 237 239 234
Not Completed 13 11 14
Arm/Group Title Standard Intensity of Anticoagulation Low Intensity and Adjusted by Elevated D-dimer Low Intensity Without Adjustment Total
Hide Arm/Group Description

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

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

The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),

Warfarin

Total of all reporting groups
Overall Number of Baseline Participants 237 239 234 710
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 237 participants 239 participants 234 participants 710 participants
48.8  (11.5) 50.4  (11.9) 50.1  (10.9) 49.8  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 237 participants 239 participants 234 participants 710 participants
Female
113
  47.7%
102
  42.7%
96
  41.0%
311
  43.8%
Male
124
  52.3%
137
  57.3%
138
  59.0%
399
  56.2%
Elevated D-dimer(n)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 237 participants 239 participants 234 participants 710 participants
17 36 38 91
1.Primary Outcome
Title Bleeding Events;
Hide Description 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.
Time Frame Up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Intensity of Anticoagulation Low Intensity and Adjusted by Elevated D-dimer Low Intensity Without Adjustment
Hide Arm/Group Description:

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

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

The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),

Warfarin

Overall Number of Participants Analyzed 237 239 234
Measure Type: Count of Participants
Unit of Measure: Participants
16
   6.8%
3
   1.3%
4
   1.7%
2.Primary Outcome
Title Thrombotic Events
Hide Description The thrombotic events included valve thrombosis, transient ischemic attack, ischemic stroke, peripheral embolism, and myocardial infarction.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Intensity of Anticoagulation Low Intensity and Adjusted by Elevated D-dimer Low Intensity Without Adjustment
Hide Arm/Group Description:

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

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

The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),

Warfarin

Overall Number of Participants Analyzed 237 239 234
Measure Type: Count of Participants
Unit of Measure: Participants
5
   2.1%
5
   2.1%
14
   6.0%
3.Secondary Outcome
Title All Cause Deaths
Hide Description The deaths from all causes
Time Frame Up to 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Intensity of Anticoagulation Low Intensity and Adjusted by Elevated D-dimer Low Intensity Without Adjustment
Hide Arm/Group Description:

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

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

The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),

Warfarin

Overall Number of Participants Analyzed 237 239 234
Measure Type: Count of Participants
Unit of Measure: Participants
12
   5.1%
4
   1.7%
5
   2.1%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Intensity of Anticoagulation D-dimer-guided Adjustmentd of Anticoagutlation Intensity Low Intensity Without Adjustment
Hide Arm/Group Description

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

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

The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),

Warfarin

All-Cause Mortality
Standard Intensity of Anticoagulation D-dimer-guided Adjustmentd of Anticoagutlation Intensity Low Intensity Without Adjustment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/245 (4.90%)   4/245 (1.63%)   5/242 (2.07%) 
Show Serious Adverse Events Hide Serious Adverse Events
Standard Intensity of Anticoagulation D-dimer-guided Adjustmentd of Anticoagutlation Intensity Low Intensity Without Adjustment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   24/245 (9.80%)   9/245 (3.67%)   20/242 (8.26%) 
Blood and lymphatic system disorders       
thrombotic envents * [1]  5/245 (2.04%)  5/245 (2.04%)  14/242 (5.79%) 
bleeding events * [2]  16/245 (6.53%)  3/245 (1.22%)  4/242 (1.65%) 
Cardiac disorders       
Deaths from other causes * [3]  3/245 (1.22%)  1/245 (0.41%)  2/242 (0.83%) 
*
Indicates events were collected by non-systematic assessment
[1]
including valve thrombosis, transient ischemic attack, ischemic stroke, peripheral embolism, and myocardial infarction.
[2]
including 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.
[3]
Death from Heart failure,Cancer or unexplained death
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Intensity of Anticoagulation D-dimer-guided Adjustmentd of Anticoagutlation Intensity Low Intensity Without Adjustment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/245 (0.00%)   0/245 (0.00%)   0/242 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr.Litao Zhang
Organization: Wuhan Asia Heart Hospital
Phone: +862765796888 ext 8204
EMail: zhengleetau@qq.com
Layout table for additonal information
Responsible Party: Wuhan Asia Heart Hospital
ClinicalTrials.gov Identifier: NCT01996657     History of Changes
Other Study ID Numbers: 2013-P-002
First Submitted: November 4, 2013
First Posted: November 27, 2013
Results First Submitted: April 9, 2017
Results First Posted: June 26, 2017
Last Update Posted: June 26, 2017