Plain English Summary
Background and study aims
A transient ischaemic attack (TIA), often referred to as a “mini stroke” is a condition caused by a temporary disruption of blood flow to the brain. This causes stroke-like symptoms, such as difficulty talking or numbness/weakness in the face, arms or legs. In the case of a TIA, these symptoms pass quickly, however when they last for more than 24 hours, it becomes a minor ischaemic stroke (MIS), so called because only minimal damage is caused. When a person has had a TIA or MIS, they have a greater risk of developing serious complications arising from blocked blood vessels (major ischemic vascular events), such as a major stroke or heart attack. In order to prevent this, patients are often prescribed antiplatelet medications, which are used to reduce the risk of blood clots forming. Aspirin is one of the most commonly used antiplatelet medications, although there are a range of other drugs available, such as clopidrogrel. The aim of this study is to find out whether treatment with clopidrogrel and aspirin is more effective at preventing future major ischemic vascular events in TIA and MIS patients than aspirin alone.
Who can participate?
Adults who have had a high-risk TIA or minor ischaemic stroke.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group take clopidogrel and aspirin for 90 days. After an initial dose of 600mg clopidogrel (so that patients can start getting an effect from the drug), patients take 75mg clopidogrel every day, as well as 50-325mg aspirin per day. Those in the second group receive dummy pills (placebo) of identical in shape and size to the clopidogrel in the same treatment regimen, as well as 50-325mg aspirin per day. Participants in both groups are followed up after 90 days in order to find out how many have gone on to have a stroke or heart attack (major ischemic vascular events).
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Acute Vascular Imaging Centre, John Radcliffe Hospital (UK)
When is the study starting and how long is it expected to run for?
January 2014 to June 2016
Who is funding the study?
National Institute of Neurological Disorders and Stroke (USA)
Who is the main contact?
Dr James Kennedy
james.kennedy@rdm.ox.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr James Kennedy
ORCID ID
Contact details
Acute Vascular Imaging Centre
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
+44 1865 572585
james.kennedy@rdm.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
15499
Study information
Scientific title
POINT: Platelet Oriented Inhibition in New TIA and Minor Ischemic stroke
Acronym
POINT
Study hypothesis
The purpose of this study is to determine the safety and effectiveness of the combination of low dose aspirin and a medication called clopidogrel (also known by the brand name Plavix®) in reducing the risk of stroke, heart attacks and other complications in patients recovering from stroke. The POINT trial has been designed to find out whether the combination of aspirin and clopidogrel reduces the risk of stroke, heart attacks and other complications compared to aspirin alone in patients.
Ethics approval
13/SC/0470
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Topic: Stroke Research Network, Injuries and Emergencies; Subtopic: Acute Care, Injuries and Emergencies (all Subtopics); Disease: In hospital study, Injuries and Emergencies
Intervention
Clopidogrel/aspirin group compared to a placebo/aspirin group.
Intervention type
Drug
Phase
Phase IV
Drug names
1. Aspirin
2. Clopidogrel
Primary outcome measure
Prevention of major ischemic vascular events at 90 days; Timepoint(s): The primary outcome of the trial is to determine whether clopidogrel 75mg/day by mouth after a load
Secondary outcome measures
Not provided at time of registration
Overall trial start date
31/01/2014
Overall trial end date
30/06/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Neurologic deficit (based on history or examination) attributed to focal brain ischemia and EITHER:
1. High risk TIA: Complete resolution of the deficit at the time of randomization AND ABCD2 score >4
Or
Minor ischemic stroke: residual deficit with NIHSS <3 at the time of randomization
2. Ability to randomize within 12 hours of time last known free of new ischemic symptoms.
3. Head CT or MRI ruling out hemorrhage or other pathology, such as vascular malformation, tumor, or abscess, that could explain symptoms or contraindicate therapy.
4. Ability to tolerate aspirin at a dose of 50-325 mg/day.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 4150; UK Sample Size: 378
Participant exclusion criteria
1. Age <18 years.
2. TIA symptoms limited to isolated numbness, isolated visual changes, or isolated dizziness/vertigo.
3. In the judgement 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.
4. Receipt of any intravenous or intraarterial thrombolysis within 1 week prior to index event.
5. Gastrointestinal bleed or major surgery within 3 months prior to index event.
6. History of nontraumatic intracranial hemorrhage.
7. 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).
8. Qualifying ischemic event induced by angiography or surgery.
9. Severe noncardiovascular comorbidity with life expectancy <3 months.
10. Contraindication to clopidogrel or aspirin:
10.1. Known allergy
10.2. Severe renal (serum creatinine >2 mg/dL) or hepatic insufficiency (prior or concurrent diagnosis, with INR>1.5, or any
resultant complication, such as variceal bleeding, encephalopathy, or icterus)
10.3. Haemostatic disorder or systemic bleeding in the past 3 months
10.4. Current thrombocytopenia (platelet count <100 x109/l) or neutropenia/granulocytopenia (<1 x109/l)
10.5. History of drug induced haematologic or hepatic abnormalities
11. Anticipated requirement for long term (>7 day) nonstudy antiplatelet drugs (e.g., dipyridamole, clopidogrel,
iclopidine), or NSAIDs affecting platelet function (such as prior vascular stent or arthritis).
12. Not willing or able to discontinue prohibited concomitant medications.
13. Inability to swallow medications.
14. 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).
15. Unavailability for followup.
16. Signed and dated informed consent not obtained from patient.
17. Other neurological conditions that would complicate assessment of outcomes during follow up.
18. Ongoing treatment in another study of an investigational therapy, or treatment in such a study within the last 7 days.
19. Previously enrolled in the POINT study.
Recruitment start date
31/01/2014
Recruitment end date
30/06/2016
Locations
Countries of recruitment
United Kingdom, United States of America
Trial participating centre
John Radcliffe Hospital
Acute Vascular Imaging Centre
Headley Way
Oxford
OX3 9DU
United Kingdom
Funders
Funder type
Government
Funder name
National Institute of Neurological Disorders and Stroke
Alternative name(s)
NINDS
Funding Body Type
government organisation
Funding Body Subtype
Research institutes and centers
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list