TISSARA Trial: Ticagrelor Intervention to Reduce Stent Thrombosis and Acute MI Risk (TISSARA)

October 29, 2024 updated by: Professor Abdul Hakeem, National Institute of Cardiovascular Diseases, Pakistan

Ticagrelor Intervention to Suppress Stent Thrombosis and Acute MI Risk (TISSARA) Trial: An LMIC Health System Initiative in the World's Busiest Primary PCI Center

Stent thrombosis (ST) remains a critical complication following primary percutaneous coronary intervention (PPCI) in patients with ST-elevation myocardial infarction (STEMI). At the National Institute of Cardiovascular Diseases in Karachi-recognized as the world's busiest PPCI center-reported rates of ST range from 4% to 6%. In response to this pressing issue, the health system has implemented a new two-week post-PCI regimen featuring ticagrelor, aimed at enhancing patient outcomes and reducing the risk of stent-related complications.

The TISSARA Trial is designed to rigorously assess the effectiveness of this intervention on cardiovascular outcomes in STEMI patients.

Between August, 2023 and March 2024, a total of 1,773 patients were enrolled in the trial, with 970 patients discharged on Tissara (Ticagrelor) (Ferozsons laboratories Ltd, Lahore, Pakistan) (TG) and 803 patients receiving clopidogrel (CG) following their primary PCI procedures. Each group was carefully monitored for a duration of three months to evaluate the incidence of stent thrombosis and other relevant cardiovascular events. The primary endpoint of this trial is the occurrence of stent thrombosis within the follow-up period, providing critical insights into the safety and efficacy of the ticagrelor regimen in this high-risk population.

This comprehensive approach aims to contribute valuable data that may influence future treatment protocols and improve the standard of care for patients undergoing PCI in similar healthcare settings.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The TISSARA Trial aims to compare the incidence rates of stent thrombosis (ST) and major adverse cardiovascular events (MACE) among patients receiving ticagrelor therapy versus those treated with conventional clopidogrel therapy following primary percutaneous coronary intervention (PPCI) f or ST elevation myocardial infarction at NICVD, Karachi, Pakistan.

Study Cohorts:

  • Ticagrelor Cohort: Comprises consecutive patients receiving ticagrelor as part of the dual antiplatelet therapy (DAPT) regimen mandated for a minimum of two weeks post PPCI.
  • Clopidogrel Cohort: Included patients who received clopidogrel as part of the conventional DAPT protocol.

Selection Criteria:

• All consecutive patients presenting with ST-elevation myocardial infarction (STEMI) and undergoing primary PCI with drug-eluting stents (DES).

Exclusion Criteria:

  • Patients who underwent plain old balloon angioplasty (POBA) or left heart catheterization (LHC) only.
  • Patients who declined to provide consent.
  • Patient with high bleeding risk
  • Prior history of IC hemorrhage
  • Prior CVA within past one year
  • On oral anticoagulant Study Variables and Operational Definitions

  • ST-Elevation Myocardial Infarction (STEMI): Diagnosis based on at least two of the following criteria:

    • Typical chest pain lasting more than 20 minutes, characterized by retrosternal pain radiating to the left arm or shoulder, worsening with exertion or emotional stress, and alleviated by rest or nitroglycerin.
    • New ST elevation in at least two contiguous leads: greater than 2 mm in men or greater than 1 mm in women in leads V2 to V3, and/or greater than 1 mm in other contiguous chest leads or limb leads.
  • Primary PCI: The strategy of directly taking a STEMI patient to the cardiac catheterization laboratory for mechanical revascularization via balloon angioplasty and coronary stenting.

  • Stent Thrombosis:

    • Definite Stent Thrombosis: Confirmed by angiographic or pathological evidence of partial or total thrombotic occlusion within the peri-stent area, along with acute ischemic symptoms, ischemic ECG changes, or elevated cardiac biomarkers.
    • Probable Stent Thrombosis: Unexplained death within 30 days of stent implantation or myocardial infarction related to documented acute ischemia in the stented territory, without angiographic confirmation of stent thrombosis.
    • Possible Stent Thrombosis: Unexplained death occurring beyond 30 days.
    • Early Stent Thrombosis: Occurs within 24 hours post-PCI.
    • Subacute Stent Thrombosis: Occurs from 24 hours to 30 days post-PCI.

  • Major Adverse Cardiovascular Events (MACE): Defined as a composite of:

    • All-cause mortality
    • Cardiovascular mortality
    • Myocardial infarction (with or without revascularization)
    • Unplanned hospitalization due to heart failure
    • Stroke or cerebrovascular events Data Collection Procedure The study was conducted after receiving approval from the ethical review committee of NICVD, Karachi. Verbal informed consent was obtained from all participants, ensuring confidentiality. Patients presenting with STEMI who underwent primary PCI with second-generation DES were included. Data on demographic characteristics, financial status, treatment compliance, complications, hospitalizations, and emergency room visits were collected using a structured questionnaire. The collected data were securely stored and accessible to the primary investigators and co-investigators. Patients were followed up at 15 days and one month in the outpatient clinic to assess medication compliance, side effects, and bleeding.

Study Type

Interventional

Enrollment (Actual)

1727

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 755000
        • National Institute of Cardiovascular Diseases

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: consecutive patients presenting with ST-elevation myocardial infarction (STEMI) and undergoing primary PCI with drug-eluting stents (DES).

-

Exclusion Criteria:

  • Patients who underwent plain old balloon angioplasty (POBA) or left heart catheterization (LHC) only.

    • Patients who declined to provide consent.
    • Patient with high bleeding risk
    • Prior history of IC hemorrhage
    • Prior CVA within past one year
    • On oral anticoagulant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tiacgrelor (Tissara) 90 mg pod BID
Ticagrelor 90 mg bid give for atleast two weeks and ideally upto a month
Drug: Ticagrelor
Ticagrelor 90 mg PO BID given for atleast two weeks following primary PCI
Other Names:
  • Brilinta
Active Comparator: standard arm clopidogrel 75 mg qday
Drug: Ticagrelor
Ticagrelor 90 mg PO BID given for atleast two weeks following primary PCI
Other Names:
  • Brilinta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stent Thrombosis
Time Frame: Stent thrombosis occurring 24 hours to 30 DAYS

A. Definite Stent Thrombosis: Angiographic or pathological confirmation of partial or total thrombotic occlusion within the peri-stent region and at least one of the following additional criteria: Acute ischemic symptoms Ischemic electrocardiogram changes Elevated cardiac biomarkers

B. Probable Stent Thrombosis:

Any unexplained death <30 days of stent implantation Any myocardial infarction related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause C. Possible Stent Thrombosis: Any unexplained death beyond 30 days D. Early Stent Thrombosis: Stent thrombosis occurring within 24 hours E. Subacute Stent Thrombosis: Stent thrombosis occurring 24 hours to 30 days
Stent thrombosis occurring 24 hours to 30 DAYS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Cardiovascular Diseases, Pakistan

Investigators

  • Principal Investigator: Abdul Hakeem, MD, National Institute of Cardiovascular Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 24, 2023

Primary Completion (Actual)

March 3, 2024

Study Completion (Actual)

June 16, 2024

Study Registration Dates

First Submitted

September 28, 2024

First Submitted That Met QC Criteria

October 29, 2024

First Posted (Actual)

October 31, 2024

Study Record Updates

Last Update Posted (Actual)

October 31, 2024

Last Update Submitted That Met QC Criteria

October 29, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NICVD IRB-40/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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