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Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial
Phase 3 trial testing Clopidogrel in Ischemic Attack, Transient in 4,881 participants. Terminated before completion.
| Lead sponsor | University of California, San Francisco |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 4,881 |
| Start date | 28 May 2010 |
| Primary completion | 9 April 2018 |
| Estimated completion | 9 April 2018 |
| Sites | 210 locations across France, New Zealand, Finland, United Kingdom, Germany, Mexico, Canada, Australia |
University of California, San Francisco
18 and older, any sex, with Ischemic Attack, Transient. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Primary efficacy outcome: Number of Participants with Ischemic Stroke, Myocardial Infarction, or Death From Ischemic Vascular Causes
| Group | Value | 95% CI |
|---|---|---|
| Clopidogrel | 121 | |
| Placebo | 160 |
Primary safety outcome: Number of Participants with major hemorrhage
| Group | Value | 95% CI |
|---|---|---|
| Clopidogrel | 23 | |
| Placebo | 10 |
Secondary efficacy outcome:Number of participants with Ischemic stroke
| Group | Value | 95% CI |
|---|---|---|
| Clopidogrel | 112 | |
| Placebo | 155 |
Secondary efficacy outcome: Number of participants with Myocardial infarction
| Group | Value | 95% CI |
|---|---|---|
| Clopidogrel | 10 | |
| Placebo | 7 |
Secondary efficacy outcome: Number of participants with Death from ischemic vascular causes
| Group | Value | 95% CI |
|---|---|---|
| Clopidogrel | 6 | |
| Placebo | 4 |
Secondary efficacy outcome: Number of participants with Ischemic or hemorrhagic stroke
| Group | Value | 95% CI |
|---|---|---|
| Clopidogrel | 116 | |
| Placebo | 156 |
Secondary efficacy outcome: Number of participants with ischemic stroke, myocardial infarction, death from ischemic vascular causes, or major hemorrhage
| Group | Value | 95% CI |
|---|---|---|
| Clopidogrel | 141 | |
| Placebo | 167 |
Other safety outcome: Number of participants with Hemorrhagic stroke
| Group | Value | 95% CI |
|---|---|---|
| Clopidogrel | 5 | |
| Placebo | 3 |
Other safety outcome: Number of participants with Symptomatic intracerebral hemorrhage
| Group | Value | 95% CI |
|---|---|---|
| Clopidogrel | 2 | |
| Placebo | 2 |
Other safety outcome: Number of participants with other symptomatic intracranial hemorrhage
| Group | Value | 95% CI |
|---|---|---|
| Clopidogrel | 2 | |
| Placebo | 0 |
Other safety outcome: Number of Participants with Major hemorrhage other than intracranial hemorrhage
| Group | Value | 95% CI |
|---|---|---|
| Clopidogrel | 17 | |
| Placebo | 7 |
Other safety outcome:Number of Participants with Minor hemorrhage
| Group | Value | 95% CI |
|---|---|---|
| Clopidogrel | 40 | |
| Placebo | 13 |
Time frame: 90 days from randomization. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Clopidogrel | Placebo |
|---|---|---|---|
| Ischaemic stroke | Nervous system disorders | — | — |
| Transient ischaemic attack | Nervous system disorders | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
| Cerebrovascular accident | Nervous system disorders | — | — |
| Carotid artery stenosis | Nervous system disorders | — | — |
| Chest pain | General disorders | — | — |
| Convulsion | Nervous system disorders | — | — |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | — | — |
| Carotid endarterectomy | Surgical and medical procedures | — | — |
| Pneumonia | Infections and infestations | — | — |
| Deep vein thrombosis | Vascular disorders | — | — |
| Hypertensive crisis | Vascular disorders | — | — |
| Syncope | Nervous system disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Coronary revascularisation | Surgical and medical procedures | — | — |
| Encephalopathy | Nervous system disorders | — | — |
| Myocardial infarction | Cardiac disorders | — | — |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | — | — |
| Renal failure acute | Renal and urinary disorders | — | — |
| Subarachnoid haemorrhage | Nervous system disorders | — | — |
| Coronary artery disease | Cardiac disorders | — | — |
| Fall | Injury, poisoning and procedural complications | — | — |
| Haemorrhagic transformation stroke | Nervous system disorders | — | — |
| Intracardiac thrombus | Cardiac disorders | — | — |
| Mental status changes | Psychiatric disorders | — | — |
| Reaction | System | Clopidogrel | Placebo |
|---|---|---|---|
| Transient ischaemic attack | Nervous system disorders | — | — |
| Ischaemic stroke | Nervous system disorders | — | — |
| Contusion | Injury, poisoning and procedural complications | — | — |
| Haemorrhage | Vascular disorders | — | — |
| Cerebrovascular accident | Nervous system disorders | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — |
| Haematochezia | Gastrointestinal disorders | — | — |
| Haemorrhagic transformation stroke | Nervous system disorders | — | — |
| Rectal haemorrhage | Gastrointestinal disorders | — | — |
| Ecchymosis | Skin and subcutaneous tissue disorders | — | — |
| Haematuria | Renal and urinary disorders | — | — |
| Acute myocardial infarction | Cardiac disorders | — | — |
| Cerebral amyloid angiopathy | Nervous system disorders | — | — |
| Conjunctival haemorrhage | Eye disorders | — | — |
| Dysfunctional uterine bleeding | Reproductive system and breast disorders | — | — |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | — | — |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | — | — |
| Haemorrhage intracranial | Nervous system disorders | — | — |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | — | — |
| Hypoaesthesia | Nervous system disorders | — | — |
| Lacunar infarction | Nervous system disorders | — | — |
| Myocardial infarction | Cardiac disorders | — | — |
| Subarachnoid haemorrhage | Nervous system disorders | — | — |
| Vaginal haemorrhage | Reproductive system and breast disorders | — | — |
Most-reported serious reactions: Ischaemic stroke, Transient ischaemic attack, Atrial fibrillation, Cerebrovascular accident, Carotid artery stenosis, Chest pain, Convulsion, Gastrointestinal haemorrhage.
Data from ClinicalTrials.gov NCT00991029 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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