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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2018
Source St. Olavs Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

The most serious adverse effect of antithrombotic therapy is bleeding. Combinations of antithrombotic agents are now frequently used (e.g. after use of drug eluting stents or after ischemic stroke), and this may lead to an increased frequency of significant bleeding complications. Among hemorrhagic complications of antithrombotic drugs, intracranial hemorrhage (ICH) may have particularly devastating consequences with high morbidity, disability and even mortality rates. Intracerebral hemorrhage (hemorrhagic stroke) is generally associated with a higher risk for death and incurs greater loss of health over a lifetime than ischemic stroke.

This makes antithrombotic therapy a double-edged sword. Although a certain risk for bleeding may be acceptable in the context of even greater protection against ischemic events, it is important to quantify the magnitude of bleeding risk. So far the efficacy and safety profile of antithrombotic agents are generally assessed in randomized controlled trials (RCT). However, extrapolating the results from randomized clinical trials to the general patient population in this context is challenging. Patients who participate in clinical trials are frequently highly selected and therefore somewhat unrepresentative. In addition, their numbers are limited and the treatment period is often much shorter than in routine management of a chronic disease or condition. Finally, patients in clinical trials are often monitored more closely than in routine practice.

The incidence of intracranial hemorrhage due to antithrombotic therapy could theoretically be monitored by post-marketing surveillance by including spontaneously reported events. Unfortunately, it seems this does not provide more reliable estimates. A recent study from Finland has shown that bleeding complications due to oral anticoagulation with Warfarin are underreported in daily clinical practice. Further, it has been shown that reporting rates of side effects following medical therapy tend to decrease over time indicating that it is more likely that adverse events to a newer drug are reported than to a drug that has been available for many years. This is why population-based large-scale pharmaco-epidemiological studies are needed, in which cohorts of patients exposed to antithrombotic medications are monitored to determine a valid and reliable risk of the treatment.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
antithrombotic drugs


Locations

Country Name City State
Norway St Olavs Hospital Trondheim

Sponsors (2)

Lead Sponsor Collaborator
St. Olavs Hospital Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (2)

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

Outcome

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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