SPARK: Safety Study of Pradxa in Atrial Fibrillation Patients by Regulatory Requirement of Korea
This study is currently recruiting participants.
Verified May 2013 by Boehringer Ingelheim Pharmaceuticals
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01774370
First received: January 16, 2013
Last updated: May 2, 2013
Last verified: May 2013
| Tracking Information | |||||
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| First Received Date ICMJE | January 16, 2013 | ||||
| Last Updated Date | May 2, 2013 | ||||
| Start Date ICMJE | January 2013 | ||||
| Estimated Primary Completion Date | February 2017 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Adverse events reported after intake of Pradaxa [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01774370 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Incidence rate of stroke and systemic embolism [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | SPARK: Safety Study of Pradxa in Atrial Fibrillation Patients by Regulatory Requirement of Korea | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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. |
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| Detailed Description | Study Design: regulatory PMS study |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Korean patients with non-valvular AF |
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| Condition ICMJE | Atrial Fibrillation | ||||
| Intervention ICMJE | Drug: Pradaxa (Dabigatran etexilate mesilate)
110 mg or 150 mg b.i.d. |
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| Study Group/Cohort (s) | Pradaxa group
Intervention: Drug: Pradaxa (Dabigatran etexilate mesilate) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 3000 | ||||
| Estimated Completion Date | February 2017 | ||||
| Estimated Primary Completion Date | February 2017 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | 19 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01774370 | ||||
| Other Study ID Numbers ICMJE | 1160.139 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Boehringer Ingelheim Pharmaceuticals | ||||
| Study Sponsor ICMJE | Boehringer Ingelheim Pharmaceuticals | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Boehringer Ingelheim Pharmaceuticals | ||||
| Verification Date | May 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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