Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT00991029 : Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial
PhasePhase 3
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Neurological deficit (based on history or exam) attributed to focal brain ischemia
and EITHER:

- High risk TIA: Complete resolution of the deficit at the time of randomization
AND ABCD2 score of (greater than or equal to) 4 OR

- Minor ischemic stroke: residual deficit with NIHSS of (less than or equal to) 3
at the time of randomization

- Ability to randomize within 12 hours of time last known free of new ischemic
symptoms.

- Head CT or MRI ruling out hemorrhage or other pathology, such as vascular
malformation, tumor, or abscess, that could explain symptoms or contraindicate
therapy.

- Ability to tolerate aspirin at a does of 50-325 mg/day.

Exclusion Criteria

- Age <18 years

- TIA symptoms limited to isolated numbness, isolated visual changes, or isolated
dizziness/vertigo.

- In the judgment of the treating physician, a candidate for thrombolysis,
endarterectomy or endovascular intervention, unless the subject declines both
endarterectomy and endovascular intervention at the time of evaluation for
eligibility.

- Receipt of any intravenous or intra-arterial thrombolysis within 1 week prior to
index event.

- Gastrointestinal bleed or major surgery within 3 months prior to index event.

- History of nontraumatic intracranial hemorrhage.

- Clear indication for anticoagulation (e.g., warfarin, heparin) anticipated during the
study period (atrial fibrillation, mechanical heart valve, deep venous thrombosis,
pulmonary embolism, antiphospholipid antibody syndrome, hypercoagulable state).

- Qualifying ischemic event induced by angiography or surgery.

- Severe non-cardiovascular comorbidity with life expectancy <3 months.

- Contraindication to clopidogrel or aspirin.

- Known allergy

- Severe renal (serum creatinine >2 mg/dL or 176.8umol/L) or hepatic insufficiency
(prior or concurrent diagnosis, with International Normalized Ratio (INR)>1.5 or
any resultant complication, such as variceal bleeding, encephalopathy, or
icterus)

- Hemostatic disorder or systemic bleeding in the past 3 months

- Current thrombocytopenia (platelet count <100 x10^9/l) or neutropenia (<1
x10^9/l)

- History of drug-induced hematologic or hepatic abnormalities

- Anticipated requirement for long-term (>7 day) non-study antiplatelet drugs (eg,
dipyridamole, clopidogrel, ticlopidine), or Non-steroidal Anti-inflammatory Drugs
(NSAIDs) affecting platelet function (such as prior vascular stent or arthritis).

- Inability to swallow medications.

- At risk for pregnancy: premenopausal or post menopausal woman within 12 months of
last menses without a negative pregnancy test or not committing to adequate birth
control (e.g., oral contraceptive, two methods of barrier birth control, or
abstinence).

- Unavailability for follow-up.

- Signed and dated informed consent not obtained from patient.

- Other neurological conditions that would complicate assessment of outcomes during
follow-up.

- Ongoing treatment in another study of an investigational therapy or treatment in such
a study within the last 7 days.

- Previously enrolled in the POINT study.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT00991029      |      Link to official Clinicaltrials.gov listing
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