SPARK: Safety Study of Pradxa in Atrial Fibrillation Patients by Regulatory Requirement of Korea - Full Text View

Purpose

This is a prospective, non-interventional, open-label, multi-centre study. It will provide additional safety information of Pradaxa in Korean patients with non-valvular AF in clinical settings.

Condition	Intervention
Atrial Fibrillation	Drug: Pradaxa (Dabigatran etexilate mesilate)

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	A Regulatory Requirement Non-interventional Study to Monitor the Safety and Effectiveness of Pradaxa (Dabigatran Etexilate Mesilate, 110 mg or 150 mg b.i.d.) in Korean Patients With Non-valvular Atrial Fibrillation

Resource links provided by NLM:

Genetics Home Reference related topics: familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation

Drug Information available for: Dabigatran Dabigatran etexilate Dabigatran etexilate mesylate

U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:

Adverse events reported after intake of Pradaxa [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence rate of stroke and systemic embolism [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	3000
Study Start Date:	January 2013
Estimated Study Completion Date:	February 2017
Estimated Primary Completion Date:	February 2017 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Pradaxa group	Drug: Pradaxa (Dabigatran etexilate mesilate) 110 mg or 150 mg b.i.d.

Detailed Description:

Study Design:

regulatory PMS study

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Korean patients with non-valvular AF

Criteria

Inclusion criteria:

Patients who have been started on Pradaxa in accordance with the approved label in Korea

Exclusion criteria:

Patient with previous experience to Pradaxa Current participation in other clinical trials or registries

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774370

Contacts

Contact: Boehringer Ingelheim Call Center

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

Locations

Korea, Republic of
Boehringer Ingelheim Investigational Site 40	Recruiting
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 14	Recruiting
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 18	Recruiting
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 16	Recruiting
Busan, Korea, Republic of
Boehringer Ingelheim Investigational Site 31	Recruiting
Chonbuk, Korea, Republic of
Boehringer Ingelheim Investigational Site 24	Recruiting
Chonbuk, Korea, Republic of
Boehringer Ingelheim Investigational Site 3	Recruiting
Chonnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 41	Recruiting
Chonnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 19	Recruiting
Chungbuk, Korea, Republic of
Boehringer Ingelheim Investigational Site 27	Recruiting
Chungnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 28	Recruiting
Chungnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 35	Recruiting
Chungnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 33	Recruiting
Daegu, Korea, Republic of
Boehringer Ingelheim Investigational Site 25	Recruiting
Daegu, Korea, Republic of
Boehringer Ingelheim Investigational Site 21	Recruiting
Geonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 32	Recruiting
Gwangju, Korea, Republic of
Boehringer Ingelheim Investigational Site 30	Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 20	Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 4	Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 29	Recruiting
Gyeonggi, Korea, Republic of
Boehringer Ingelheim Investigational Site 38	Recruiting
Incheon, Korea, Republic of
Boehringer Ingelheim Investigational Site 10	Recruiting
Jeju, Korea, Republic of
Boehringer Ingelheim Investigational Site 7	Recruiting
Jeju, Korea, Republic of
Boehringer Ingelheim Investigational Site 6	Recruiting
Jeju, Korea, Republic of
Boehringer Ingelheim Investigational Site 34	Recruiting
Kangwon, Korea, Republic of
Boehringer Ingelheim Investigational Site 23	Recruiting
Kyungnam, Korea, Republic of
Boehringer Ingelheim Investigational Site 12	Recruiting
Kyungpook, Korea, Republic of
Boehringer Ingelheim Investigational Site 9	Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 15	Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 17	Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 8	Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 5	Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 11	Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 26	Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 2	Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 36	Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 37	Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 22	Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 39	Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 1	Recruiting
Seoul, Korea, Republic of
Boehringer Ingelheim Investigational Site 13	Recruiting
Seoul, Korea, Republic of

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

More Information

No publications provided

Responsible Party:	Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01774370 History of Changes
Other Study ID Numbers:	1160.139
Study First Received:	January 16, 2013
Last Updated:	May 2, 2013
Health Authority:	South Korea: Ministry of Food and Drug Safety (MFDS)

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013