RELY-ABLE Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Boehringer Ingelheim

ClinicalTrials.gov Identifier:

NCT00808067

First received: December 12, 2008

Last updated: June 3, 2014

Last verified: March 2014

History of Changes

Results First Received: December 20, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double-Blind; Primary Purpose: Treatment
Condition:	Atrial Fibrillation
Interventions:	Drug: dabigatran dose 1 Drug: dabigatran dose 2

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 5897 subjects were enrolled (rolled over from RE-LY trial), and 5891 were entered in this study. There were 8 subjects not treated; therefore 5883 subjects comprise the 'started' treatment group.

Reporting Groups

	Description
Dabigatran 110 mg	Dabigatran etexilate 110 mg twice daily
Dabigatran 150 mg	Dabigatran etexilate 150 mg twice daily

Participant Flow: Overall Study

	Dabigatran 110 mg	Dabigatran 150 mg
STARTED	2927 ^[1]	2956 ^[1]
COMPLETED	2446	2438
NOT COMPLETED	481	518
Major/minor bleed	30	44
Outcome event - other	33	25
Adverse Event	111	121
Hospitalization (not including surgery)	18	17
Hospitalization due to surgery	37	40
Reduced creatinine clearance	53	55
Elevated LFT results	7	3
Patient refused to take study medication	65	76
Missing	1	0
Death	1	1
Procedure	6	7
Withdrawal by Subject	21	25
Site closed	4	3
Physician Decision	47	38
Protocol Violation	3	11
Patient elected	7	9
Site closed for cause	19	19
Other reason not defined above	5	5
Excluded from analysis	13	19

^[1]	Number of patients which are treated.

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.
SAF - Safety set; included all treated subjects, but excluded subjects from sites 1059 and 0246.

Reporting Groups

	Description
Dabigatran 110 mg	Dabigatran etexilate 110 mg twice daily
Dabigatran 150 mg	Dabigatran etexilate 150 mg twice daily
Total	Total of all reporting groups

Baseline Measures

	Dabigatran 110 mg	Dabigatran 150 mg	Total
Overall Participants Analyzed [Units: Participants]	2914	2937	5851

Age [Units: Years] Mean (Standard Deviation)	73.1 (8.4)	73.1 (8.4)	73.1 (8.4)

Gender [Units: Participants]
Female	1000	1026	2026
Male	1914	1911	3825

Outcome Measures

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1. Primary:

Major Bleeding, Annualized Rate of Subjects With Major Bleeds [ Time Frame: up to 43 months ]

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2. Secondary:

Stroke, Annualized Rate of Subjects With Stroke [ Time Frame: up to 43 months ]

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3. Secondary:

Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE [ Time Frame: up to 43 months ]

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4. Secondary:

Pulmonary Embolism (PE), Annualized Rate of Subjects With PE [ Time Frame: up to 43 months ]

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5. Secondary:

Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI [ Time Frame: up to 43 months ]

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6. Secondary:

Deep Vein Thrombosis, Annualized Rate of Subjects With DVT [ Time Frame: up to 43 months ]

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7. Secondary:

Death, Annualized Rate of Subject Death [ Time Frame: up to 43 months ]

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8. Secondary:

Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) [ Time Frame: up to 43 months ]

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9. Secondary:

Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) and All Cause Death [ Time Frame: up to 43 months ]

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10. Secondary:

Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction, Vascular Death [ Time Frame: up to 43 months ]

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11. Secondary:

Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction (MI), All Cause Death and Major Bleed [ Time Frame: up to 43 months ]

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12. Secondary:

Annualized Rate of Subjects With Minor Bleeds [ Time Frame: up to 43 months ]

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13. Secondary:

Annualized Rate of Subjects With Any Bleeds (Major Plus Minor) [ Time Frame: up to 43 months ]

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14. Secondary:

Annualized Rate of Subjects With Intra-Cranial Hemorrhage (ICH) [ Time Frame: up to 43 months ]

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Serious Adverse Events

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Other Adverse Events

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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
Non-serious adverse events were not collected on subjects in this study.

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.

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):

Connolly SJ, Wallentin L, Ezekowitz MD, Eikelboom J, Oldgren J, Reilly PA, Brueckmann M, Pogue J, Alings M, Amerena JV, Avezum A, Baumgartner I, Budaj AJ, Chen JH, Dans AL, Darius H, Di Pasquale G, Ferreira J, Flaker GC, Flather MD, Franzosi MG, Golitsyn SP, Halon DA, Heidbuchel H, Hohnloser SH, Huber K, Jansky P, Kamensky G, Keltai M, Kim SS, Lau CP, Le Heuzey JY, Lewis BS, Liu L, Nanas J, Omar R, Pais P, Pedersen KE, Piegas LS, Raev D, Smith PJ, Talajic M, Tan RS, Tanomsup S, Toivonen L, Vinereanu D, Xavier D, Zhu J, Wang SQ, Duffy CO, Themeles E, Yusuf S. The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) Study. Circulation. 2013 Jul 16;128(3):237-43. doi: 10.1161/CIRCULATIONAHA.112.001139. Epub 2013 Jun 14.

Responsible Party:	Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00808067 History of Changes
Other Study ID Numbers:	1160.71 2008-005248-17 ( EudraCT Number: EudraCT )
Study First Received:	December 12, 2008
Results First Received:	December 20, 2013
Last Updated:	June 3, 2014

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