The Middle East Dual Anti-platelet Treatment in Acute Transient Ischemic Attack

NCT02144831 | Withdrawn Phase 4 DMC

• 1 other identifier: MENA-TIA study
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Transient Ischemic Attacks; Minor Stroke

Keywords

TIA; stroke prevention; ASA; clopidogrel; dual antiplatelet treatment

Outcome Measures

Primary Outcomes (2)

• To test if 10 days of treatment with ASA and Clopidogrel has fewer complications than 30 days of similar treatment

  Initiation of dual anti platelet treatment in high risk TIA patients within 24 hours of presentation

  4 years prospective study

• What is the feasibility and efficacy of the non-inferiority design

  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

  4 years

Secondary Outcomes (1)

• To study the incidence of hemorrhagic complications

  4 years

Study Arms (2)

anti-thrombotic treatment

ACTIVE COMPARATOR

10 days of ASA (75-325 mg) + Clopidogrel (75mg) anti-thrombotic treatment

Drug: anti-thrombotic treatment using Aspirin (ASA 75-325mg) and Clopidogrel (75mg)

anti-thrombotic

ACTIVE COMPARATOR

30 days of ASA (75-325 mg) + Clopidogrel (75mg) anti-thrombotic treatment

Drug: anti-thrombotic treatment using Aspirin (ASA 75-325mg) and Clopidogrel (75mg)

Interventions

anti-thrombotic treatment using Aspirin (ASA 75-325mg) and Clopidogrel (75mg) DRUG

comparisson of what is the efficacy and safety of 10 days to 30 day treatment of aspirin (ASA)+Clopidogrel

anti-thrombotic; anti-thrombotic treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Ability to randomize within 24 hours of time last known free of new ischemic symptoms.
• Head CT or MRI ruling out hemorrhage or other pathology, such as vascular malformation, tumor, or abscess, that could explain symptoms or contraindicate therapy.
• Ability to tolerate aspirin at a dose of 50-325 mg/day.

You may not qualify if:

• TIA symptoms limited to isolated numbness, isolated visual changes, or isolated dizziness/vertigo.
• 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.
• Receipt of any intravenous or intra-arterial thrombolysis within 1 week prior to index event.
• Gastrointestinal bleed or major surgery within 3 months prior to index event. History of non-traumatic intracranial hemorrhage.
• 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).
• Qualifying ischemic event induced by angiography or surgery.
• Severe non-cardiovascular comorbidity with life expectancy \<3 months.
• 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
• 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).
• Not willing or able to discontinue prohibited concomitant medications. Inability to swallow medications.
• 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).

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

MeSH Terms

Conditions

Ischemic Attack, Transient

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ashfaq Shuaib, MD FRCPC

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2014
• First Posted: May 22, 2014
• Study Start: July 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: October 1, 2018
• Last Updated: May 27, 2022

Record last verified: 2022-05

Locations

CA (1)