EARLY 3-months Aggrenox Treatment Started Within 24 Hrs of Ischemic Stroke Onset vs. After One Week 100 mg ASA

This study has been completed.

Study NCT00562588 Information provided by Boehringer Ingelheim Pharmaceuticals

First Received on July 6, 2007. Last Updated on July 1, 2010 History of Changes

Results First Received: January 29, 2010

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Primary Purpose: Treatment
Condition:	Cerebrovascular Accident
Interventions:	Drug: Aggrenox bid (ASA 25mg/Dipyridamole ER 200mg) Drug: ASA 100 mg qd

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
551 patients enrolled, 548 randomized, 543 treated; analysis is based on treated patients

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Aspirin for 7 Days, Followed by Aggrenox	No text entered.
Aggrenox	No text entered.

Participant Flow: Overall Study

	Aspirin for 7 Days, Followed by Aggrenox	Aggrenox
STARTED	260	283
COMPLETED	168	184
NOT COMPLETED	92	99
Adverse Event	40	58
Protocol Violation	30	26
Lost to Follow-up	12	4
Withdrawal by Subject	10	9
unknown	0	2

Baseline Characteristics

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Reporting Groups

	Description
Aspirin for 7 Days, Followed by Aggrenox	No text entered.
Aggrenox	No text entered.

Baseline Measures

	Aspirin for 7 Days, Followed by Aggrenox	Aggrenox	Total
Number of Participants [units: participants]	260	283	543
Age [units: Years] Mean ± Standard Deviation	68.3 ± 11.5	66.5 ± 11.4	67.3 ± 11.5
Gender [units: participants]
Female	95	109	204
Male	165	174	339

Outcome Measures

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1. Primary:

Telephone Modified Rankin Scale (Centralised, Blinded Assessment) [ Time Frame: 90 days ]

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2. Secondary:

Change From Baseline in NIHSS (National Institutes of Health Stroke Scale) [ Time Frame: Baseline and 90 days ]

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3. Secondary:

Patients With Relevant Event (Death, Non-fatal Stroke, Transient Ischaemic Attack (TIA), Myocardial Infarction (MI), Bleeding) [ Time Frame: 90 days ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com

No publications provided by Boehringer Ingelheim Pharmaceuticals

Publications automatically indexed to this study:

Dengler R, Diener HC, Schwartz A, Grond M, Schumacher H, Machnig T, Eschenfelder CC, Leonard J, Weissenborn K, Kastrup A, Haberl R; EARLY investigators. Early treatment with aspirin plus extended-release dipyridamole for transient ischaemic attack or ischaemic stroke within 24 h of symptom onset (EARLY trial): a randomised, open-label, blinded-endpoint trial. Lancet Neurol. 2010 Feb;9(2):159-66. Epub 2010 Jan 7.

Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00562588 History of Changes
Other Study ID Numbers:	9.182
Study First Received:	July 6, 2007
Results First Received:	January 29, 2010
Last Updated:	July 1, 2010
Health Authority:	Germany: BfArM (Bundesagentur fuer Arzneimittel und Medizinalprodukte)