ASSESSMENT OF SECONDARY RECURRENCE OF STROKE IN ASPIRIN-CLOPIDOGREL COMBINATION THERAPY AND ASPIRIN MONOTHERAPY IN TRANSIENT ISCHEMIC ATTACK PATIENTS IN SOUTH INDIA- A COMPARATIVE STUDY

Author(s)

Pal M1, Prasad O2, Fatima A1, Bakki C3, Ahmed M4
1St.Peter's Institute of Pharmaceutical Sciences, Warangal,Telangana, India, 2Rohini Super speciality Hospitals, Warangal, India, 3St peter's Institute of Pharmaceutical sciences, Warangal, India, 4St.Peter's Institute of Pharmaceutical Sciences, Warangal, India

OBJECTIVES: TIA is a prognostic indicator of stroke. Stroke is the prime cause of mortality within the nation, the circumstances has touched a borderline from where improvisation of the enduring therapy have become vital. The prime objective is to establish the safety and efficacy outcome of dual therapy of Aspirin and Clopidogrel within 12 hours of index event of TIA, as they are considered safe and effective when administered alone in stroke. METHODS: A randomized, double-blind, placebo-controlled study, conducted on patients diagnosed with TIA, and those accomplishing the study criteria are enrolled into study. We randomly enrolled 150 patients to combination therapy of clopidogrel and aspirin and on aspirin monotherapy. The study cohort was followed for 3 months and based on clinician’s evaluation, ABCD2 scoring and CT or MRI scanning, secondary recurrence of stroke was determined. RESULTS: Occurrence of stroke was seen in 7.5% patients in the aspirin-clopidogrel group,as compared with 24.24% of those in the aspirin group. Out of 132 patients, 64(48.48%) and 68 (51.52%) patients were on dual and monotherapy respectively.Patients on dualtherapy, 6.06% experienced severe GI bleeding, 15.91% experienced mild GI bleeding and 26.52% had no bleeding. Similarly, patients on monotherapy, 0% patients experienced severe GI bleeding, 3.03% experienced mild GI bleeding and 48.48% patients had no bleeding. The recurrence of major stroke is significantly lower (P<0.0001) in patients who were randomized within 12 hours of the index event when compared with patients randomized in 24hrs. CONCLUSIONS: Our study demonstrates that, clopidogrel plus aspirin therapy is superior to aspirin in reducing the subsequent recurrence of secondary event of TIA  within 12 hours of index event.The execution of the study with a multicenter approach will provide the health policy and decision makers with an applicable document to promote dual therapy over monotherapy in Indian population.

Conference/Value in Health Info

2016-09, ISPOR Asia Pacific 2016, Singapore

Value in Health, Vol. 19, No. 7 (November 2016)

Code

PCV6

Topic

Clinical Outcomes

Topic Subcategory

Comparative Effectiveness or Efficacy

Disease

Cardiovascular Disorders

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