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

NCT06667349 | Completed Phase 4 DMC

• 1 other identifier: NICVD IRB-40/2023
• Study Type: interventional
• Target: 1,727
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

STEMI - ST Elevation Myocardial Infarction; Stent Thrombosis; Antiplatelet Agents

Keywords

clinical trial; STEMI; stent thrombosis; ticagrelor; clopidogrel; health care intervention

Outcome Measures

Primary Outcomes (1)

• Stent Thrombosis

  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

Study Arms (2)

Tiacgrelor (Tissara) 90 mg pod BID

EXPERIMENTAL

Ticagrelor 90 mg bid give for atleast two weeks and ideally upto a month

Drug: Ticagrelor

standard arm clopidogrel 75 mg qday

ACTIVE COMPARATOR

Drug: Ticagrelor

Interventions

Ticagrelor DRUG

Ticagrelor 90 mg PO BID given for atleast two weeks following primary PCI

Also known as: Brilinta

Tiacgrelor (Tissara) 90 mg pod BID; standard arm clopidogrel 75 mg qday

Eligibility Criteria

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Cardiovascular Diseases, Pakistan: lead

Study Sites (1)

National Institute of Cardiovascular Diseases

Karachi, Sindh, 755000, Pakistan

Location

Related Publications (3)

• Kumar R, Ammar A, Saghir T, Sial JA, Shah JA, Kumar A, Shaikh AH, Achakzai AS, Qamar N, Karim M. Incidence, Predictors, and Outcomes of Acute and Sub-acute Stent Thrombosis after Emergency Percutaneous Coronary Revascularization with Drug-Eluting Stents: A Prospective Observational Study. Glob Heart. 2022 Mar 30;17(1):24. doi: 10.5334/gh.1112. eCollection 2022.

  PMID: 35586746 BACKGROUND

• Schulz S, Schuster T, Mehilli J, Byrne RA, Ellert J, Massberg S, Goedel J, Bruskina O, Ulm K, Schomig A, Kastrati A. Stent thrombosis after drug-eluting stent implantation: incidence, timing, and relation to discontinuation of clopidogrel therapy over a 4-year period. Eur Heart J. 2009 Nov;30(22):2714-21. doi: 10.1093/eurheartj/ehp275. Epub 2009 Jul 11.

  PMID: 19596658 BACKGROUND

• Dubey G, Verma SK, Bahl VK. Primary percutaneous coronary intervention for acute ST elevation myocardial infarction: Outcomes and determinants of outcomes: A tertiary care center study from North India. Indian Heart J. 2017 May-Jun;69(3):294-298. doi: 10.1016/j.ihj.2016.11.322. Epub 2016 Nov 30.

  PMID: 28648416 BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Abdul Hakeem, MD

  National Institute of Cardiovascular Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Abdul Hakeem MD FACC FSCAI FASE

Model Details: 1727

Study Record Dates

• First Submitted: September 28, 2024
• First Posted: October 31, 2024
• Study Start: August 24, 2023
• Primary Completion: March 3, 2024
• Study Completion: June 16, 2024
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

PA (1)