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DATA ABSTRACTION FORM

Anticoagulants and Antiplatelet Agents in Acute Ischemic Stroke

Abstractor Initials:

First Author:Journal:

Ref No.

Inclusion Criteria:

 Relevant clinical end point (death, disability, functional status, neurological outcome, or a combination thereof)

 Human studies only

 Intervention within 48 hours

 Stroke with treatment within 48 hours (if subjects with onset of symptoms > 48 hours were also entered in the protocol, there must be an analyzable subgroup within 48 hours)

Treatment with anticoagulant, antiaggregant, or a combination thereof

If patients with TIA were also entered in the protocol, there must be an analyzable subgroup who were enrolled because of stroke

Exclusion Criteria:

Did not include patients treated within 48 hours or provide subgroup analysis permitting analysis of patients treated within 48 hours

 TIA's only

 Case reports

 Studies that are confined to lab measures

No relevant clinical endpoint

Studies with thrombolytic, fibrinogenolytic, and hemorheologicalagents

SAH or primary intracerebral hemorrhage

Animal study

Meta analysis

Cerebral vein occlusion dural sinus thrombosis

Class IV evidence

Type of Study:

Randomized prospective, double blinded

Randomized prospective, not blinded

Prospective case control

Retrospective

Case series

Opinion/editorial letter

Systematic review

Meta-analysis

Multicenter Study

Single Center Study

Population Studied:

Age:______mean; ______median Control group

Age:______mean; ______median RX group

Gender: _____%male; _____%female

Racial Comp: ______%White; ______%Black; ______%Hispanic;

______%Other; ______Unknown

Sample Size: ______Rx group;______Control group

Date study started:______; Completion:______; Duration:______

Types of patients[LBG1]:

Stroke subtypes:

Stroke severity at entry:

Mandated screening tests prior to entry:

______Head CT

______Serum glucose

______Blood pressure measurement

______Coagulation studies

______Complete blood count

How many hours after time of onset of symptoms did treatment need to be initiated? ____, or not specified ___

Primary Treatment

When given:

Duration of treatment:

Dose:

Route of administration:

Safety/Side Effects:

Secondary or additional or concomitant treatments: (list and describe)

Outcome measures: ______Barthel Scale

______Modified Rankin

______NIHSS

______Glasgow Outcome Scale

______Other

______Not addressed

Average length of follow-up: ______

Greatest length of follow-up: ______

Primary outcome:

RX (N, %) / Control (N,%) / p
Nonfatal new stroke
Nonfatal progressing stroke
Death
Functional Outcome
Other (list)
Measurement system

Secondary outcomes:

(List and describe any secondary outcome results)

(Describe any analysis of cost benefit of the treatment)

(If the outcome is positive, is there evidence that the benefit persists i.e. treatment group better at 1 week but no different from control at 3 months)

Complications:

RX (N, %) / Control (N, %) / p
Intracranial hemorrhage
Major systemic hemorrhage*
Minor systemic hemorrhage*

*Definitions (Major: life threatening, prolonging hospitalization, requiring transfusion, or other significant intervention)

COMMENTS:

Overall (should be based on primary aims):

Subgroup analysis (Pre-determined):

Other Complications of treatment:

Durability (Did benefit persist over time)

OTHER COMMENTS:

Does the article address a relevant question?

If yes which one/ones:

If not please comment:

BOTTOM LINE:

[LBG1]1 Indicate system of determination, TOAST, Oxfordshire, Other, Not Described. For severity, give system of measurement. Also, should indicate whether the groups were balanced