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Secondary Prevention of Venous Thrombo Embolism (VTE). (RE-MEDY)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00329238
First received: May 23, 2006
Last updated: May 8, 2014
Last verified: December 2013
Results First Received: August 10, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Thromboembolism
Interventions: Drug: Dabigatran
Drug: Warfarin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Dabigatran 150 mg twice daily, total daily dose 300 mg
Warfarin Target International Normalized Ratio (INR) of 2.0 to 3.0

Participant Flow:   Overall Study
    Dabigatran     Warfarin  
STARTED     1430 [1]   1426 [1]
COMPLETED     1154     1145  
NOT COMPLETED     276     281  
Adverse Event                 147                 129  
Protocol Violation                 23                 34  
Lost to Follow-up                 2                 6  
Withdrawal by Subject                 64                 58  
Other reason (not specified)                 40                 54  
[1] 2866 were randomized. A total of ten did not receive treatment resulting in 2856 starting study.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The FAS consisted of all randomised patients who were documented to have taken at least 1 dose of study drug.

Reporting Groups
  Description
Dabigatran 150 mg twice daily, total daily dose 300 mg
Warfarin Target International Normalized Ratio (INR) of 2.0 to 3.0
Total Total of all reporting groups

Baseline Measures
    Dabigatran     Warfarin     Total  
Number of Participants  
[units: participants]
  1430     1426     2856  
Age  
[units: years]
Mean ± Standard Deviation
  55.38  ± 14.99     53.90  ± 15.34     54.64  ± 15.18  
Age, Customized  
[units: participants]
     
>=18 to <40 years     237     269     506  
>=40 to <50 years     250     291     541  
>=50 to <65 years     500     459     959  
>=65 to <75 years     303     288     591  
>= 75 years     140     119     259  
Gender  
[units: Participants]
     
Female     559     555     1114  
Male     871     871     1742  
Race/Ethnicity, Customized  
[units: Participants]
     
Not Hispanic/Latino     1325     1317     2642  
Hispanic/Latino     105     109     214  
Race/Ethnicity, Customized  
[units: Participants]
     
White     1288     1284     2572  
Black     29     28     57  
Asian     113     114     227  
Height [1]
[units: cm]
Mean ± Standard Deviation
  171.55  ± 9.73     171.95  ± 10.08     171.75  ± 9.90  
Weight [2]
[units: kg]
Mean ± Standard Deviation
  86.09  ± 19.26     85.95  ± 18.87     86.02  ± 19.06  
Weight category  
[units: Participants]
     
< 50 kg     10     5     15  
>= 50 to < 100 kg     1120     1117     2237  
>= 100 kg     299     300     599  
Missing     1     4     5  
Body Mass Index (BMI) [3]
[units: kg/square meter]
Mean ± Standard Deviation
  29.15  ± 5.65     29.01  ± 5.75     29.08  ± 5.70  
Body Mass Index (BMI) category  
[units: Participants]
     
<25 kg/square meter     315     334     649  
>=25 to <30 kg/square meter     571     584     1155  
>=30 to <35 kg/square meter     356     330     686  
>= 35 kg/square meter     186     174     360  
Missing     2     4     6  
Smoking history  
[units: Participants]
     
Non-smoker     814     829     1643  
Ex-smoker     393     366     759  
Current smoker     223     231     454  
Serum creatinine clearance [4]
[units: mL/min]
Mean ± Standard Deviation
  104.2  ± 38.6     106.6  ± 37.9     105.4  ± 38.3  
Serum creatinine clearance category  
[units: Participants]
     
>=0 to <30 mL/min     0     4     4  
>=30 to <50 mL/min     59     45     104  
>=50 to <80 mL/min     328     289     617  
>= 80 mL/min     1031     1072     2103  
Missing     12     16     28  
[1] N = 1429, 1424, 2853
[2] N = 1429, 1422, 2851
[3] N = 1428, 1422, 2850
[4] N = 1418, 1410, 2828



  Outcome Measures
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1.  Primary:   Composite of Recurrent VTE or VTE Death at 36 Months   [ Time Frame: 36 months ]

2.  Primary:   Composite of Recurrent VTE or VTE Death at 18 Months   [ Time Frame: 18 months ]

3.  Secondary:   Composite of Recurrent VTE or All Cause Death at 36 Months   [ Time Frame: 36 months ]

4.  Secondary:   Composite of Recurrent VTE or All Cause Death at 18 Months   [ Time Frame: 18 months ]

5.  Secondary:   Deep Vein Thrombosis (DVT) at 36 Months   [ Time Frame: 36 months ]

6.  Secondary:   DVT at 18 Months   [ Time Frame: 18 months ]

7.  Secondary:   Symptomatic Pulmonary Embolism (PE) at 36 Months   [ Time Frame: 36 months ]

8.  Secondary:   Symptomatic Pulmonary Embolism (PE) at 18 Months   [ Time Frame: 18 months ]

9.  Secondary:   Deaths Related to VTE at 36 Months   [ Time Frame: 36 months ]

10.  Secondary:   Deaths Related to VTE at 18 Months   [ Time Frame: 18 months ]

11.  Secondary:   Deaths of All Causes at 36 Months   [ Time Frame: 36 months ]

12.  Secondary:   Deaths of All Causes at 18 Months   [ Time Frame: 18 months ]

13.  Secondary:   Number of Participants With Bleeding Events   [ Time Frame: first intake of study drug until 6 days following last intake of study drug ]

14.  Secondary:   Laboratory Analysis   [ Time Frame: 18 months + 30 days follow up ]

15.  Secondary:   Number of Participants With Definite Acute Coronary Syndrome (ACS)   [ Time Frame: day of first study drug intake until last day of study drug intake; from the day after last intake of study drug until trial termination ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided by Boehringer Ingelheim

Publications automatically indexed to this study:

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00329238     History of Changes
Other Study ID Numbers: 1160.47, 2005-002536-94
Study First Received: May 23, 2006
Results First Received: August 10, 2011
Last Updated: May 8, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Dept of Health and Ageing Therapeutic Goods Admin
Austria: Bundesamt für Sicherheit im Gesundheitswesen, A-1030 Vienna
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia
Canada: Health Canada, Therapeutic Products Directorate
China: Ministry of Health
Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10
Denmark: The Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: BfArM-Federal Authorities for Drugs and Medical Devices
Great Britain: MHRA
Greece: National Organization for Medicines (EOF) National Ethics Committee
Hungary: National Institute of Pharmacy, H-1051 Budapest
India: Drug Control General of India
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Comitato Etico delle Aziende Sanitarie dell'Umbria di Perugia
Mexico: Comisión Federal para la Protección contra Riesgos Sanitarios COFEPRIS Federal Commission for Protection against Sanitary Hazards
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
New Zealand: Multicentre Ethics Committee/Medsafe
Norway: Norwegian Medicines Agency (Statens Legemiddelverk)
Poland: Registration Medicinal Product Medical Device Biocidal Product
Portugal: INFARMED, National Authority of Medicines and Health Products, IP
Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow
Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26
South Africa: Medicines Control Council
Spain: Spanish Agency for Medicines and Health Products
Sweden: Medical Products Agency Regional Ethical Review Board
Turkey: Ministry of Health Central Ethics Committee
Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)
United States: Food and Drug Administration