Transient Ischemic Attack Clinical Trial
— PICNIC-ONEOfficial title:
Feasibility of Applying Remote Ischemic Conditioning in Secondary Prevention in Patients With Minor Ischemic Stroke or Transient Ischemic Attack —A Single-arm Futility Study
Verified date | January 2018 |
Source | Capital Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a single-arm, open-labeled and phase II futility study. Application of Remote ischemic conditioning (RIC) as an adjunctive therapy to medication were involved in the study. The study is to test whether RIC is effective in preventing ischemic evens after a minor ischemic stroke/transient ischemic attack within 3 months and to explore the safety and compliance of chronic RIC. Medication strategy is based on physician's best judgement.
Status | Completed |
Enrollment | 167 |
Est. completion date | October 19, 2017 |
Est. primary completion date | October 19, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: 1. Eighteen years old or older of any gender or race; 2. Diagnosed with a non-cardiogenic MIS/TIA within 14 days; MIS is defined by an ischemic stroke of score of 3 or less on the NIHSS at the time of inclusion, TIA is defined as neurologic deficit attributed to focal brain ischemia, with symptoms resolution within 24 h of symptom onset, Symptom onset is defined by the "last see normal" principle; 3. Stable vital signs, normal cardiac, hepatic and renal functions; 4. Able to consent by himself/herself or by legally authorized representative. Exclusion Criteria: 1. Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor, abscess or other non-vascular diseases, based on brain CT or MRI; 2. Modified Rankin Scale score > 2 at inclusion; 3. Received iv. recombinant tissue plasminogen activator (rtPA) therapy or interventional treatment for the current event; 4. Contradiction for aspirin or clopidogrel (known allergy, severe asthma or heart failure et al.) ; 5. Clear indication for anticoagulation therapy ( cardiac source of embolus); 6. Hemorrhagic tendency of any reason (including but not limit to Hemostatic disorder, platelet count <100 × 109/L, history of drug-induced hepatic dysfunction); 7. Any hemorrhagic transformation; 8. Gastrointestinal bleed or major surgery within 3 months of symptoms onset; 9. Stroke or TIA induced by interventional therapy or surgery; 10. Any upper extremity soft tissue, vascular injury or peripheral blood vessel disease which may contraindicate RIC; 11. Systolic blood pressure greater than 200 mmHg after medication; 12. Planned revascularization (any angioplasty or vascular surgery) within the next 3 months ; 13. Scheduled for surgery or interventional treatment requiring RIC cessation within next 3 months; 14. Severe noncardiovascular comorbidity with life expectancy < 3 months; 15. Pregnancy; 16. Currently receiving an investigational drug or device by other studies. |
Country | Name | City | State |
---|---|---|---|
China | Xuanwu Hospital, Capital Medical University | Beijing | Beijing |
China | Taoyuan People's Hospital | Changde | Hunan |
China | Shengli Oilfield Center Hospital | Dongying | Shandong |
China | First Affiliated Hospital of Hainan Medical University | Haikou | Hainan |
Lead Sponsor | Collaborator |
---|---|
Capital Medical University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Recurrent rate of ischemic stroke/transient ischemic stroke within 1 months | within 1 months | ||
Primary | Recurrent rate of ischemic stroke/transient ischemic stroke | within 3 months | ||
Secondary | Treatment-Related Adverse Events | pain and tolerability, redness, bleeding, palpitation | within 3 months | |
Secondary | Compliance of remote ischemic conditioning | the proportion of patients fulfill the treatment | within 3 months | |
Secondary | Incidence rate of vascular events | hemorrhage stroke, myocardial infarction and vascular death | within 3 months | |
Secondary | Improvements in NIH Stroke Scale | improvements in NIH Stroke Scale in patients without recurrence or vascular events | within1, 3 months | |
Secondary | Improvements in modified Rankin Scale | improvements in modified Rankin Scale Scale in patients without recurrence or vascular events | within 1, 3 months | |
Secondary | Improvements in Barthel Scale | improvements in Barthel Scale in patients without recurrence or vascular events | within 1,3 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT00859885 -
International PFO Consortium
|
N/A | |
Not yet recruiting |
NCT03605355 -
Feasibility Study on the Medical and Economic Consequences of Outpatient Management of TIAs and Minor Strokes
|
||
Completed |
NCT03281590 -
Stroke and Cerebrovascular Diseases Registry
|
||
Completed |
NCT02905383 -
The Effect of Exercise on Physical Function and Health in Older People After Discharge From Hospital
|
N/A | |
Completed |
NCT04078737 -
Clopidogrel With Aspirin in High-risk Patients With Acute Non-disabling Cerebrovascular Events II
|
Phase 3 | |
Completed |
NCT02141932 -
Pocket-size Cardiovascular Ultrasound in Stroke
|
N/A | |
Recruiting |
NCT01954329 -
Markers in the Diagnosis of TIA
|
N/A | |
Completed |
NCT02011256 -
Early Detection Of Atrial Fibrillation In Patients With Transient Ischemic Attack
|
N/A | |
Completed |
NCT01918891 -
Center for Stroke Disparities Solution - Community Transitions Intervention
|
N/A | |
Recruiting |
NCT01526824 -
Lovaza's Effect on Clopidogrel in a Neuro Population
|
Phase 0 | |
Completed |
NCT01020851 -
The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating Transient Ischemic Attack (TIA) or Stroke Trial
|
N/A | |
Completed |
NCT00597974 -
Neurological Outcome With Carotid Artery Stenting
|
N/A | |
Completed |
NCT00211731 -
Preventing Recurrent Stroke in Minority Populations
|
N/A | |
Active, not recruiting |
NCT03635749 -
Intensive Medical Therapy for High-risk Intracranial or Extracranial Atherosclerosis
|
Phase 3 | |
Completed |
NCT03153020 -
Determinants of Adherence to Post-stroke/Transient Ischemic Attack Secondary Prevention Treatment: Cohort Study in the Rhône
|
||
Recruiting |
NCT04075500 -
Optimal Detection of Atrial Fibrillation in TIA
|
N/A | |
Recruiting |
NCT06091319 -
Florbetaben for Imaging of Vascular Amyloid
|
||
Completed |
NCT04604015 -
RoBotic TCD Ultrasound BubbLe Study Compared to Transthoracic Echocardiography for Detection of Right to Left Shunt
|
N/A | |
Completed |
NCT00885456 -
Program of Rehabilitative Exercise and Education to Avert Vascular Events After Non-disabling Stroke or Transient Ischemic Attack: A Multi-site RCT
|
Phase 2 | |
Completed |
NCT05620966 -
EEG to Diagnose TIA and Stroke
|