Excessive Warfarin Anticoagulation - Causes and Consequences (EWA)
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ClinicalTrials.gov Identifier: NCT02761941 |
Recruitment Status : Unknown
Verified May 2016 by Juhani Airaksinen, University of Turku.
Recruitment status was: Recruiting
First Posted : May 4, 2016
Last Update Posted : May 5, 2016
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Condition or disease |
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Anticoagulation |
This is a retrospective study setting. Source data will be collected by reviewing medical records and through computer searches. The basic study population will be identified from laboratory INR test results taken between 2003-2015.
Identifying patients with INR values over 9 will be selected for further analysis, concerning the clinical presentation, patient characteristics, 90 day survival and adverse event rates. The focus is in identifying patient characteristics and factors influencing the risk of high INR value. Also we will analyse the effects of medically reversing the high INR values on stroke and other adverse event rates. The results will be collected manually using an electronic case report form, and analysed statistically using SPSS/SAS statistics tool.
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 25000 participants |
Observational Model: | Cohort |
Target Follow-Up Duration: | 90 Days |
Official Title: | Excessive Warfarin Anticoagulation - Causes and Consequences |
Study Start Date : | May 2016 |
Estimated Primary Completion Date : | December 2019 |
Estimated Study Completion Date : | December 2019 |

- All cause mortality [ Time Frame: 90 days ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- VKA treatment, age > 18, INR >9,
Exclusion Criteria:
- age < 18

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02761941
Contact: Tuija Vasankari, RN | +358 2 3130900 | tuija.vasankari@tyks.fi |
Finland | |
Turku University Hospital | Recruiting |
Turku, Finland | |
Contact: Juhani Airaksinen, prof +35823131005 juhani.airaksinen@tyks.fi | |
Contact: Tuomas Kiviniemi, MD, PhD +35823130787 tuoski@utu.fi | |
Principal Investigator: Juhani Airaksinen, Prof | |
Sub-Investigator: Tuomas Kiviniemi, MD, PhD | |
Sub-Investigator: Fausto Biancari, MD, PhD | |
Sub-Investigator: Samuli Jaakkola, MD | |
Sub-Investigator: Ilpo Nuotio, MD, PhD |
Principal Investigator: | Juhani Airaksinen, Professor | Turku University Hospital |
Additional Information:
Responsible Party: | Juhani Airaksinen, Professor of Cardiology, University of Turku |
ClinicalTrials.gov Identifier: | NCT02761941 History of Changes |
Other Study ID Numbers: |
T80/2016 |
First Posted: | May 4, 2016 Key Record Dates |
Last Update Posted: | May 5, 2016 |
Last Verified: | May 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Warfarin Anticoagulants |