Risk of Intracranial Hemorrhage in Users of Oral Antithrombotic Drugs (RICH)

August 24, 2018 updated by: St. Olavs Hospital

Risk of Intracranial Hemorrhage in Users of Oral Antithrombotic Drugs: a Nationwide Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

22111

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • St Olavs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with intracranial hemorrhage admitted to hospitals in Norway 2008-2014

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
users
patients on antithrombotic drugs admitted to a Norwegian hospital for intracranial hemorrhage (ICH)
Drug: antithrombotic drugs
non-users
patients not on antithrombotic drugs admitted to a Norwegian hospital for intracranial hemorrhage (ICH)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence rate of intracranial hemorrhage (ICH) requiring hospitalization
Time Frame: 6 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall survival following ICH
Time Frame: 6 years
comparison of users and non-users of oral antithrombotic drugs
6 years
proportion of ICH patients undergoing neurosurgical procedures
Time Frame: 6 years
comparison of users and non-users of oral antithrombotic drugs
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Olavs Hospital

Collaborators

Norwegian University of Science and Technology

Investigators

  • Study Director: Sasha Gulati, md phd, Norwegian University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

June 22, 2015

First Submitted That Met QC Criteria

June 24, 2015

First Posted (Estimate)

June 25, 2015

Study Record Updates

Last Update Posted (Actual)

August 28, 2018

Last Update Submitted That Met QC Criteria

August 24, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/7958

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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