Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery

This study has been completed.

Study NCT00168818 Information provided by Boehringer Ingelheim Pharmaceuticals

First Received on September 12, 2005. Last Updated on January 17, 2011 History of Changes

Results First Received: November 18, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double-Blind; Primary Purpose: Prevention
Conditions:	Thromboembolism Arthroplasty, Replacement, Hip
Interventions:	Drug: dabigatran etexilate Drug: enoxaparin

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
The treatment period is from first administration of study medication, until 3 days after last administration of study medication. Treatment duration is planned for 28 - 35 days. The study period is from first administration of study medication until day 84 - 91.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Whilst 3494 patients were enrolled/randomised to treatment prior to surgery in this trial, only 3463 started treatment. Therefore, 31 patients were randomised but not treated (treatment was planned to start post surgery).

Reporting Groups

	Description
Dabigatran 220mg	qd (once daily) oral
Dabigatran 150mg	qd (once daily) oral
Enoxaparin	40mg qd (once daily) subcutaneous

Participant Flow for 2 periods

Period 1: Overall Study

	Dabigatran 220mg	Dabigatran 150mg	Enoxaparin
STARTED	1146	1163	1154
COMPLETED	1029	1054	1030
NOT COMPLETED	117	109	124
Adverse Event	23	29	31
Protocol Violation	16	11	11
Lost to Follow-up	13	4	15
Withdrawal by Subject	43	41	37
not specified	22	24	30

Period 2: Treatment

	Dabigatran 220mg	Dabigatran 150mg	Enoxaparin
STARTED	1146	1163	1154
COMPLETED	1013	1012	1021
NOT COMPLETED	133	151	133
Adverse Event	77	89	68
Protocol Violation	8	11	11
Lost to Follow-up	0	2	1
Withdrawal by Subject	25	20	22
not specified	23	29	31

Baseline Characteristics

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Reporting Groups

	Description
Dabigatran 220mg	qd (once daily) oral
Dabigatran 150mg	qd (once daily) oral
Enoxaparin	40mg qd (once daily) subcutaneous

Baseline Measures

	Dabigatran 220mg	Dabigatran 150mg	Enoxaparin	Total
Number of Participants [units: participants]	1146	1163	1154	3463
Age [units: Years] Mean ± Standard Deviation	64.6 ± 10.4	63.4 ± 11.1	63.8 ± 10.8	63.9 ± 10.8
Gender [units: Participants]
Female	636	667	651	1954
Male	510	496	503	1509
Body Mass Index [units: kg/m^2] Mean ± Standard Deviation	27.7 ± 4.6	27.8 ± 4.6	27.5 ± 4.3	27.7 ± 4.5

Outcome Measures

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1. Primary:

Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period [ Time Frame: 28 - 35 days ]

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2. Secondary:

Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period [ Time Frame: 28 - 35 days ]

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3. Secondary:

Proximal Deep Vein Thrombosis During Treatment Period [ Time Frame: 28 - 35 days ]

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4. Secondary:

Total Deep Vein Thrombosis During Treatment Period [ Time Frame: 28 - 35 days ]

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5. Secondary:

Symptomatic Deep Vein Thrombosis During Treatment Period [ Time Frame: 28 - 35 days ]

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6. Secondary:

Pulmonary Embolism During Treatment Period [ Time Frame: 28 - 35 days ]

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7. Secondary:

Death During Treatment Period [ Time Frame: 28 - 35 days ]

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8. Secondary:

Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period [ Time Frame: 3 months ]

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9. Secondary:

Major Bleeding Events During Treatment Period [ Time Frame: 28 - 35 days ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract

Limitations and Caveats

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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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 Pharmaceuticals

Publications automatically indexed to this study:

Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, Prins MH, Hettiarachchi R, Hantel S, Schnee J, Buller HR; RE-NOVATE Study Group. Dabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. Lancet. 2007 Sep 15;370(9591):949-56.

Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00168818 History of Changes
Other Study ID Numbers:	1160.48, 2004-001988-21
Study First Received:	September 12, 2005
Results First Received:	November 18, 2010
Last Updated:	January 17, 2011
Health Authority:	Australia: Therapeutic Goods Administration; Austria:; Belgium: Federal Agency for Medicines and Health Products; Czech Republic: SUKL; Denmark: Danish Medicines Agency; Finland: Finnish Medicines Agency; France: Agence Francaise de Securite Sanitaire des Produits de Sante; Germany: Bundesamt fuer Strahlenschutz; Hungary:; Italy: Comitato di Bioetica IRCCS Policlinico San Matteo Viale Golgi, 19 - 27100 PAVIA; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Norway: Norwegian Medicines Agency; Poland: CEBK; South Africa: Medicines Control Council; Spain: Agencia Española de Medicamentos y Productos Santarios; Sweden: MPA