Stroke Clinical Trial
— RICHOfficial title:
Risk of Intracranial Hemorrhage in Users of Oral Antithrombotic Drugs: a Nationwide Study
NCT number | NCT02481011 |
Other study ID # | 2014/7958 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2015 |
Est. completion date | January 1, 2016 |
Verified date | August 2018 |
Source | St. Olavs Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The true incidence and risks of intracranial hemorrhage (ICH) in patients on various
antithrombotic treatments remain unknown. Here a nationwide study is conducted to investigate
the risk for and incidence rates of ICH in users and non-users of various oral antithrombotic
drugs in Norway between 2008 through 2014.
Hopefully, this study will contribute to a more responsible prescription pattern of
antithrombotic medications.
Status | Completed |
Enrollment | 22111 |
Est. completion date | January 1, 2016 |
Est. primary completion date | January 1, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - hospitalization due to intracranial hemorrhage (ICH) - residential address in Norway Exclusion Criteria: - Traumatic (high-energy) intracranial injury - Parenteral antithrombotic treatment - ICH related to tumor or vascular malformation |
Country | Name | City | State |
---|---|---|---|
Norway | St Olavs Hospital | Trondheim |
Lead Sponsor | Collaborator |
---|---|
St. Olavs Hospital | Norwegian University of Science and Technology |
Norway,
Gulati S, Solheim O, Carlsen SM, Øie LR, Jensberg H, Gulati AM, Giannadakis C, Jakola AS, Salvesen Ø. Risk of intracranial hemorrhage in users of oral antithrombotic drugs: Study protocol for a nationwide study. F1000Res. 2015 Dec 30;4:1519. doi: 10.12688/f1000research.7633.1. eCollection 2015. — View Citation
Gulati S, Solheim O, Carlsen SM, Øie LR, Jensberg H, Gulati AM, Madsbu MA, Giannadakis C, Jakola AS, Salvesen Ø. Risk of intracranial hemorrhage (RICH) in users of oral antithrombotic drugs: Nationwide pharmacoepidemiological study. PLoS One. 2018 Aug 23; — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | incidence rate of intracranial hemorrhage (ICH) requiring hospitalization | We will determine the incidence rates of ICH in users and non-users of oral antithrombotic treatment by linking data from Norwegian Patient Register (NPR) and the Norwegian prescription database. | 6 years | |
Secondary | overall survival following ICH | comparison of users and non-users of oral antithrombotic drugs | 6 years | |
Secondary | proportion of ICH patients undergoing neurosurgical procedures | comparison of users and non-users of oral antithrombotic drugs | 6 years |
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