Condition category
Circulatory System
Date applied
25/02/2014
Date assigned
25/02/2014
Last edited
07/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.pointtrial.org/

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 measures

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

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

Sponsor information

Organisation

University of California

Sponsor details

Neurovascular Disease and Stroke Center
400 Parnassus Ave
Eighth Floor
San Francisco
94143
United States of America

Sponsor type

University/education

Website

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

federal/national government

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

07/03/2016: Plain English summary added, verifying study status with principal investigator.