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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 
Overall Participants Analyzed 
[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) 
[1] N = 1429, 1424, 2853
Weight [1] 
[Units: Kg]
Mean (Standard Deviation)
 86.09  (19.26)   85.95  (18.87)   86.02  (19.06) 
[1] N = 1429, 1422, 2851
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) [1] 
[Units: Kg/square meter]
Mean (Standard Deviation)
 29.15  (5.65)   29.01  (5.75)   29.08  (5.70) 
[1] N = 1428, 1422, 2850
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 [1] 
[Units: mL/min]
Mean (Standard Deviation)
 104.2  (38.6)   106.6  (37.9)   105.4  (38.3) 
[1] N = 1418, 1410, 2828
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 


  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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00329238     History of Changes
Other Study ID Numbers: 1160.47
2005-002536-94 ( EudraCT Number: EudraCT )
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