Stroke Trials Registry

ABBA
Acute Brain Bleeding Analysis

Principal Investigator
Byung-Woo Yoon, MD, PhD.

PI Address
Seoul National University Hospital, Seoul, Republic of Korea

Contact Email
bwyoon@snu.ac.kr

Sponsor

Study Size Actual:	940
Centers Actual:	33
Max Time from onset:	30 Days
Max Age:	84
Min Age:	30

Status:
Study complete. Results presented in February 2005.

Purpose:
To assess the risk of hemorrhagic stroke in patients taking low dose Phenylpropanolamine or other sympathomimetics.

Location(s):
Korea

Year Started: 2002

Year Finished: 2004

Year Presented: 2005

Year Published: 2008

Design:
Prospective, multi-center, case-control study.

Inclusion Criteria
Patients with intracerebral, subarachnoid or intraventricular hemorrhage within 30 days of enrollment, the absence of a previously diagnosed brain lesion, and the absence of communication problems.

Patient Involvement:
Each case was matched to two controls (hospital and community) on age and sex. Each participant was administered a questionnaire regarding lifestyle and recent pharmaceutical use.

Results:
There were 940 subjects and 1880 controls in this study. Adjusted odds ratios for hemorrhage were 2.14 (95% CI, 0.94 - 4.84) for all patients, 3.86 (95% CI, 1.08 - 13.80) for women, and 1.75 (95% CI, .045 - 4.15) for men.

Comments:
As a result of this study cold remedies containing PPA were banned by the Korean FDA.

Source of Information:
Presented at the 2005 International Stroke Conference (February 2005).

Web Links and Publications:

Nonaspirin nonsteroidal anti-inflammatory drugs and hemorrhagic stroke risk: the Acute Brain Bleeding Analysis study.
Stroke 2008 Mar;39(3):845-9

Phenylpropanolamine contained in cold remedies and risk of hemorrhagic stroke.
Neurology 2007 Jan 9;68(2):146-9

This information last updated on: 7/16/2008

Reviewed on: 07/21/2008.

UID: 558