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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00991029




Registration number
NCT00991029
Ethics application status
Date submitted
6/10/2009
Date registered
7/10/2009
Date last updated
4/12/2018

Titles & IDs
Public title
Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial
Scientific title
Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial
Secondary ID [1] 0 0
1U01S062835-01A1
Universal Trial Number (UTN)
Trial acronym
POINT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischemic Attack, Transient 0 0
Condition category
Condition code
Stroke 0 0 0 0
Ischaemic
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Clopidogrel
Treatment: Drugs - placebo

Active comparator: clopidogrel - Patients assigned to clopidogrel in addition to aspirin

Placebo comparator: placebo - Patients assigned to placebo in addition to aspirin


Treatment: Drugs: Clopidogrel
Loading dose of 600mg followed by 75 milligrams, oral, one tablet daily for 89 days

Treatment: Drugs: placebo
Loading dose of 8 tablets followed by one tablet daily for 89 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes
Timepoint [1] 0 0
Up to 90 days
Primary outcome [2] 0 0
Major Hemorrhage
Timepoint [2] 0 0
Up to 90 days
Secondary outcome [1] 0 0
Ischemic Stroke
Timepoint [1] 0 0
Up to 90 days
Secondary outcome [2] 0 0
Myocardial Infarction
Timepoint [2] 0 0
Up to 90 days
Secondary outcome [3] 0 0
Death From Ischemic Vascular Causes
Timepoint [3] 0 0
Up to 90 days
Secondary outcome [4] 0 0
Ischemic or Hemorrhagic Stroke
Timepoint [4] 0 0
Up to 90 days
Secondary outcome [5] 0 0
Composite of Ischemic Stroke, Myocardial Infarction, Death From Ischemic Vascular Causes, or Major Hemorrhage
Timepoint [5] 0 0
Up to 90 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/04/2018
Sample size
Target
Accrual to date
Final
4881
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Gosford Hospital - Gosford
Recruitment hospital [2] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [3] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [4] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [5] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [6] 0 0
The Northern Hospital - Epping
Recruitment hospital [7] 0 0
Footscray Hospital - Footscray
Recruitment hospital [8] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [9] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
- Gosford
Recruitment postcode(s) [2] 0 0
- New Lambton
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
- Box Hill
Recruitment postcode(s) [5] 0 0
- Clayton
Recruitment postcode(s) [6] 0 0
- Epping
Recruitment postcode(s) [7] 0 0
- Footscray
Recruitment postcode(s) [8] 0 0
- Heidelberg
Recruitment postcode(s) [9] 0 0
- Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
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Colorado
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United States of America
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Connecticut
Country [5] 0 0
United States of America
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Delaware
Country [6] 0 0
United States of America
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District of Columbia
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Florida
Country [8] 0 0
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Georgia
Country [9] 0 0
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Hawaii
Country [10] 0 0
United States of America
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Illinois
Country [11] 0 0
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Iowa
Country [12] 0 0
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Kansas
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Kentucky
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Montana
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New Hampshire
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New Jersey
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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Rhode Island
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South Carolina
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Tennessee
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Texas
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Virginia
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Wisconsin
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Alberta
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Ontario
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Helsinki
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Turku
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Bron
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France
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Paris
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France
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Suresnes
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Germany
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Baden-Württemberg
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Germany
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Bad Neustadt an der Saale
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Germany
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Berlin
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Germany
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Bremen
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Germany
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Essen
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Germany
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Frankfurt
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Heidelberg
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Germany
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Kiel
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Germany
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Leipzig
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Germany
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Munster
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Mexico
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Hidalgo
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Mexico
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San Luis Potosi
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Mexico
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Sinaloa
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Mexico
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Mexico City
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New Zealand
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Auckland
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Spain
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Barcelona
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Spain
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Bilbao
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Burgos
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Donostia
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Girona
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Spain
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Valencia
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Spain
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Zaragoza
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United Kingdom
State/province [69] 0 0
Cambridge
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United Kingdom
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Glasgow
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United Kingdom
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Harrow
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United Kingdom
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London
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United Kingdom
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Luton
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United Kingdom
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Oxford
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United Kingdom
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Somerset
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Southampton
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Stoke-on-Trent

Funding & Sponsors
Primary sponsor type
Other
Name
University of California, San Francisco
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Neurological Emergencies Treatment Trials Network (NETT)
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Medical University of South Carolina
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/industry
Name [3] 0 0
The Emmes Company, LLC
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
S. Claiborne Johnston, MD, PhD
Address 0 0
University of Texas - Austin
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00991029