| CTRI Number |
CTRI/2025/11/097339 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparison of aspirin-ticagrelor vs aspirin-clopidrogrel for secondary prevention of stroke or transient ischemic attack- A randomized trial |
|
Scientific Title of Study
|
COMPARISON OF ASPIRIN AND TICAGRELOR VERSUS ASPIRIN AND CLOPIDOGREL IN SECONDARY PREVENTION OF STROKE/ TRANSIENT ISCHEMIC ATTACK AMONG PATIENTS WITH ACUTE MINOR ISCHEMIC STROKE/ HIGH RISK TRANSIENT ISCHEMIC ATTACK-A RANDOMIZED CONTROL TRIAL |
| Trial Acronym |
DAPT in acute ischemic stroke/ high risk TIA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SURESHKRISHNA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES |
| Address |
Pondicherry institute of medical sciences, ganapathichettikulam, kalapet, puducherry-605014
Pondicherry institute of medical sciences, ganapathichettikulam, kalapet, puducherry-605014
Pondicherry
PONDICHERRY
605014
India |
| Phone |
8903388925 |
| Fax |
|
| Email |
gmsgsuresh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR.NAYYAR IQBAL |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT |
| Affiliation |
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES |
| Address |
Pondicherry institute of medical sciences, ganapathichettikulam, kalapet, puducherry-605014
Pondicherry institute of medical sciences, ganapathichettikulam, kalapet, puducherry-605014
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9629180164 |
| Fax |
|
| Email |
drinayyar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SURESHKRISHNA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES |
| Address |
Pondicherry institute of medical sciences, ganapathichettikulam, kalapet, puducherry-605014
Pondicherry institute of medical sciences, ganapathichettikulam, kalapet, puducherry-605014
Pondicherry
PONDICHERRY
605004
India |
| Phone |
8903388925 |
| Fax |
|
| Email |
gmsgsuresh@gmail.com |
|
|
Source of Monetary or Material Support
|
| PONDICHERRY INSTITUTE OF MEDICAL SCIENCES |
|
|
Primary Sponsor
|
| Name |
SURESHKRISHNA |
| Address |
pondicherry institute of medical sciences, ganapathichettikulam, kalapet, puducherry-605014 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DRNAYYAR IQBAL |
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES, GANAPATHICHETTIKULAM, KALAPET, PUDUCHERRY-605014 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DRSURESHKRISHNA |
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES |
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES, GENERAL MEDICINE DEPARTMENT, GANAPATHICHETTIKULAM
KALAPET, PUDUCHERRY-605014
Pondicherry
PONDICHERRY |
8903388925
gmsgsuresh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS INSTITUTE ETHICS COMMITTEE(IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CLOPIDROGREL AND ASPIRIN |
T.ASPIRIN 75MG OD + T.CLOPIDOGREL 75MG OD X 21 DAYS FOLLOWED BY T.ASPIRIN 75 MG OD |
| Intervention |
TICAGRELOR AND ASPIRIN |
T.ASPIRIN 75MG OD + T.TICAGRELOR 90MG BD X 21 DAYS FOLLOWED BY T.ASPIRIN 75MG OD |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
a)Age 18 years and above both genders
b)Acute minor ischemic stroke NIHSS score less than or equal to 7
c)High risk transient ischemic attack ABCD2 score greater than or equal to 4
d)Symptom onset within 72 hours |
|
| ExclusionCriteria |
| Details |
a)A known bleeding diathesis or coagulation disorder
b)Patients with cardio-embolic stroke or those planned for use of anticoagulation
c)Patients with history of hemorrhagic stroke or Intracranial hemorrhages in the last 3 months
d) Patients with history of major surgeries in the last 30 days
e) Hypersensitivity to any of the trial drugs
f)Patients with thrombocytopenia less than 1 lakh
g)Pregnant women & lactating mothers
h)History of thrombolysis in the last 6 months for any cause
i)Patients already on dual antiplatelet therapy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the difference in incidence of recurrent stroke or TIA within 90 days among patients with acute minor ischemic stroke or high risk Transient ischemic attack receiving ticagrelor versus clopidogrel in addition to aspirin |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a)To determine the functional outcomes in both groups using the Modified Rankin Scale (mRS)
b)To estimate the incidence of Major adverse cardiovascular events (MACE) in both groups
c)To estimate the incidence of major bleeding in both groups
|
90 days |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
22/11/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomized controlled trial titled Comparison of Aspirin and Ticagrelor versus Aspirin and Clopidogrel in Secondary Prevention of Stroke or Transient Ischemic Attack among Patients with Acute Minor Ischemic Stroke High Risk Transient Ischemic Attack aims to evaluate the comparative efficacy of two dual antiplatelet regimens in preventing recurrent cerebrovascular events. Conducted at the Pondicherry Institute of Medical Sciences from July 2025 to June 2027 the study will enroll 70 patients aged 18 years or older presenting within 72 hours of a minor ischemic stroke NIHSS less than or equal to 7 or high risk TIA ABCD2 greater than or equal to 4. Participants will be randomized equally to receive either aspirin plus ticagrelor or aspirin plus clopidogrel for 21 days followed by aspirin monotherapy. The primary outcome is the incidence of recurrent stroke or TIA within 90 days while secondary outcomes include functional outcomes major adverse cardiovascular events and major bleeding. Data analysis will be performed using SPSS with statistical significance set at p less than 0.05. The study hypothesizes that aspirin plus ticagrelor will provide superior protection against recurrent ischemic events especially relevant for the Indian population with a high prevalence of CYP2C19 loss of function alleles that may reduce clopidogrel efficacy. Ethical clearance has been obtained and informed consent will be secured from all participants. The findings are expected to guide optimization of dual antiplatelet therapy for secondary stroke prevention in the Indian context. |