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The Middle East Dual Anti-platelet Treatment in Acute Transient Ischemic Attack (MENA-TIA)

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ClinicalTrials.gov Identifier: NCT02144831
Recruitment Status : Unknown
Verified December 2014 by Ashfaq Shuaib, University of Alberta.
Recruitment status was:  Not yet recruiting
First Posted : May 22, 2014
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):
Ashfaq Shuaib, University of Alberta

Brief Summary:
The primary goal of the research is to determine if 10 days of dual anti-platelet treatment is as effective as 30 days of similar treatment in the prevention of stroke, myocardial ischemia (MI) and death in patients with TIAs and minor stroke.

Condition or disease Intervention/treatment Phase
Transient Ischemic Attacks Minor Stroke Drug: anti-thrombotic treatment using Aspirin (ASA 75-325mg) and Clopidogrel (75mg) Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: The Middle East Dual Anti-platelet Treatment in Acute Transient Ischemic Attack.10 vs 30 Days of Combination ASA and Clopidogrel Study
Study Start Date : July 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: anti-thrombotic treatment
10 days of ASA (75-325 mg) + Clopidogrel (75mg) anti-thrombotic treatment
Drug: anti-thrombotic treatment using Aspirin (ASA 75-325mg) and Clopidogrel (75mg)
comparisson of what is the efficacy and safety of 10 days to 30 day treatment of aspirin (ASA)+Clopidogrel

Active Comparator: anti-thrombotic
30 days of ASA (75-325 mg) + Clopidogrel (75mg) anti-thrombotic treatment
Drug: anti-thrombotic treatment using Aspirin (ASA 75-325mg) and Clopidogrel (75mg)
comparisson of what is the efficacy and safety of 10 days to 30 day treatment of aspirin (ASA)+Clopidogrel




Primary Outcome Measures :
  1. To test if 10 days of treatment with ASA and Clopidogrel has fewer complications than 30 days of similar treatment [ Time Frame: 4 years prospective study ]
    Initiation of dual anti platelet treatment in high risk TIA patients within 24 hours of presentation

  2. What is the feasibility and efficacy of the non-inferiority design [ Time Frame: 4 years ]
    If 10 days of dual anti platelet treatment has equal efficacy in stroke prevention as 30 days of dual anti platelet treatment in patients with recent high risk TIAs


Secondary Outcome Measures :
  1. To study the incidence of hemorrhagic complications [ Time Frame: 4 years ]
    Safety outcome will be the measurement hemorrhagic complication within thirty days of initiation of treatment. To test if 10 days of treatment with ASA and Clopidogrel has fewer complications than 30 days of similar treatment



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Neurologic 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 age, blood pressure, clinical features, duration of TIA and presence of diabetes (ABCD2) score >4 OR Minor ischemic stroke: residual deficit with NIHSS ≤3 at the time of randomization.

  2. Ability to randomize within 24 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.

Exclusion Criteria

  1. TIA symptoms limited to isolated numbness, isolated visual changes, or isolated dizziness/vertigo.
  2. 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 the evaluation for eligibility.
  3. Receipt of any intravenous or intra-arterial thrombolysis within 1 week prior to index event.
  4. Gastrointestinal bleed or major surgery within 3 months prior to index event. History of non-traumatic intracranial hemorrhage.
  5. 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).
  6. Qualifying ischemic event induced by angiography or surgery.
  7. Severe non-cardiovascular comorbidity with life expectancy <3 months.
  8. Contraindication to clopidogrel or aspirin:

    • Known allergy
    • Severe renal (serum creatinine >2 mg/dL) 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 x109/l) or neutropenia/granulocytopenia (<1 x109/l) o History of drug-induced hematologic or hepatic abnormalities
  9. Anticipated requirement for long-term (>10 days) nonstudy antiplatelet drugs (eg, dipyridamole, clopidogrel, ticlopidine), or non steroidal anti inflammatory drugs (NSAIDs) affecting platelet function (such as prior vascular stent or arthritis).
  10. Not willing or able to discontinue prohibited concomitant medications. Inability to swallow medications.
  11. At risk for pregnancy: premenopausal or postmenopausal 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).
  12. 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, or treatment in such a study within the last 7 days.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02144831


Contacts
Contact: Ashfaq Shuaib, MD FRCPC 780 407 3254 ashfaq.shuaib@ualberta.ca
Contact: Khurshid Khan, MD FRCPC 780 407 7363 khurshid.khan@ualberta.ca

Locations
Canada, Alberta
University of Alberta Hospital Not yet recruiting
Edmonton, Alberta, Canada
Contact: ashfaq shuaib, MD FRCPC    780 407 3254    ashfaq.shuaib@ualberta.ca   
Contact: Khurshid Khan, MD FRCPC    780 407 7363    khurshid.khan@ualberta.ca   
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Ashfaq Shuaib, MD FRCPC University of Alberta

Responsible Party: Ashfaq Shuaib, Professor of Neurology and Medicine, University of Alberta
ClinicalTrials.gov Identifier: NCT02144831     History of Changes
Other Study ID Numbers: MENA-TIA study
First Posted: May 22, 2014    Key Record Dates
Last Update Posted: December 30, 2014
Last Verified: December 2014

Keywords provided by Ashfaq Shuaib, University of Alberta:
TIA
stroke prevention
ASA
clopidogrel
dual antiplatelet treatment

Additional relevant MeSH terms:
Ischemia
Ischemic Attack, Transient
Pathologic Processes
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Aspirin
Ticlopidine
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists