Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial



Status:Terminated
Conditions:Peripheral Vascular Disease, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:18 - Any
Updated:12/6/2018
Start Date:May 28, 2010
End Date:April 9, 2018

Use our guide to learn which trials are right for you!

A transient ischemic attack (TIA) is a transient episode of neurological dysfunction caused
by focal brain, spinal cord, or retinal ischemia, without acute infarction. An ischemic
stroke is a cerebral infarction. In POINT, eligibility is limited to brain TIAs and to minor
ischemic strokes (with an NIH Stroke Scale [NIHSS] score less than or equal to 3).

TIAs are common [25], and are often harbingers of disabling strokes. Approximately
250,000-350,000 TIAs are diagnosed each year in the US. Given median survival of more than 8
years [32], there are approximately 2.4 million TIA survivors. In a national survey, one in
fifteen of those over 65 years old reported a history of TIA [33], which is equivalent to a
prevalence of 2.3 million in older Americans. Based on the prevalence of undiagnosed
transient neurological events, the true incidence of TIA may be twice as high as the rates of
diagnosis [33]. Based on our review of the National Inpatient Sample for 1997-2003, there
were an average of 200,000 hospital admissions for TIA each year, with annual charges
climbing quickly in the period to $2.6 billion in 2003.

Composite endpoint of new ischemic vascular events: ischemic stroke, myocardial infarction or
ischemic vascular death at 90 days.

Platelet-Oriented Inhibition in New TIA and minor ischemic stroke (POINT) Trial, is a
prospective, randomized, double-blind, multicenter trial with the primary null hypothesis
that, in patients with TIA or minor ischemic stroke treated with aspirin 50-325 mg/day, there
is no difference in the event-free survival at 90 days in those treated with clopidogrel (600
mg loading dose then 75 mg/day) compared to placebo when subjects are randomized within 12
hours of time last known free of new ischemic symptoms.

Its primary objective is to determine whether clopidogrel 75 mg/day by mouth after a loading
dose of 600 mg of clopidogrel is effective in preventing major ischemic vascular events
(ischemic stroke, myocardial infarction, and ischemic vascular death) at 90 days when
initiated within 12 hours of TIA or minor ischemic stroke onset in patients receiving aspirin
50-325 mg/day (with a dose of 150-200 mg daily for 5 days followed by 75-100 mg daily
strongly recommended).

Patients over 18 years of age with high-risk TIA (defined as an ABCD2 score greater than or
equal to 4) or minor ischemic stroke (with NIHSS less than or equal to 3) who can be treated
within 12 hours of time last known free of new ischemic symptoms will be enrolled.

Subjects will be randomized 1:1 (clopidogrel: placebo), controlling for clinical center. A
study participant's eligibility will be determined by site personnel prior to accessing the
Randomization Module in the WebDCU™, a web-enabled clinical trials management system that was
developed by the NETT Statistics and Data Management Center (SDMC) at Medical University of
South Carolina (MUSC).Qualified users will access the Randomization Interface and complete a
protocol-specific eligibility checklist. If the Randomization Interface finds the patient to
be eligible based on the information provided, a randomization number and a confirmatory
e-mail are generated.

Each subject is followed for 90 days from randomization; the trial will be completed in 7
years.

A total of 5,840 patients will be recruited. Recruitment will occur over 90 months, with a
goal rate of 0.40 subjects/site/month for US sites, and a goal rate of 0.47
subjects/site/month for OUS sites. Current participating sites can be found at:
http://www.pointtrial.org/node/18.

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 that may potentially
interact with study drug, or treatment in such a study within the last 7 days.

- Previously enrolled in the POINT study.
We found this trial at
148
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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185 Cambridge Street
Boston, Massachusetts 02114
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75 Francis street
Boston, Massachusetts 02115
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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450 Clarkson Avenue
Brooklyn, New York 11203
(718) 270-1000
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234 Goodman Dr
Cincinnati, Ohio 45229
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9500 Euclid Avenue
Cleveland, Ohio 44106
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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6071 West Outer Drive
Detroit, Michigan 48235
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
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Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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4805 Northeast Glisan Street
Portland, Oregon 97213
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Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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593 Eddy Street
Providence, Rhode Island 02903
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Sacramento, California 95814
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4502 Medical Drive
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1200 Old York Road
Abington, Pennsylvania 19001
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Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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525 E Market St
Akron, Ohio 44304
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Allentown, Pennsylvania 18103
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80 Jesse Hill Jr Dr SE
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550 Peachtree St NE
Atlanta, Georgia 30308
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Atlanta, Georgia 30322
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1 Cooper Plaza
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57 Ray C Hunt Drive
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251 E Huron St
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1653 W. Congress Parkway
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2139 Auburn Ave
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2500 Metrohealth Dr
Cleveland, Ohio 44109
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5 Richland Medical Park Dr
Columbia, South Carolina 29203
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1 Wyoming St,
Dayton, Ohio 45409
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2799 W Grand Blvd
Detroit, Michigan 48202
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1 Medical Village Drive
Edgewood, Kentucky 41017
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6401 France Ave S
Edina, Minnesota 55435
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2650 Ridge Ave.
Evanston, Illinois 60201
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4900 Houston Road
Florence, Kentucky 41042
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30 Prospect Ave
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Honolulu, Hawaii 96813
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200 Hawkins Dr,
Iowa City, Iowa 52242
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Jacksonville, Florida 32209
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1 Medical Center Dr
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Lexington, Kentucky 40536
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2900 W Oklahoma Ave
Milwaukee, Wisconsin 53215
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Minneapolis, Minnesota 55454
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800 E 28th St
Minneapolis, Minnesota 55407
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20 York St, N20 York St,
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