STEMI - ST Elevation Myocardial InfarctionPhase 4TISSARANCT06667349
TISSARA Trial: Ticagrelor Intervention to Reduce Stent Thrombosis and Acute MI Risk
A Phase 4 study testing Ticagrelor in people with STEMI - ST Elevation Myocardial Infarction and Stent Thrombosis, run by National Institute of Cardiovascular Diseases, Pakistan at 1 site in Pakistan.
Trial 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%… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction, Stent Thrombosis, Antiplatelet Agents
- What is being tested?
- Ticagrelor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,727 participants
- Where
- 1 sitePakistan
- Study dates
- 24 Aug 2023to 16 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
National Institute of Cardiovascular Diseases
Karachi, Sindh, 755000
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Ticagrelor
- Keywords
- clinical trial, STEMI, stent thrombosis, ticagrelor, clopidogrel, health care intervention
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Also called Brilinta
Ticagrelor 90 mg PO BID given for atleast two weeks following primary PCI
| Study group | Role | What they receive |
|---|---|---|
| Tiacgrelor (Tissara) 90 mg pod BID | Experimental | Ticagrelor 90 mg bid give for atleast two weeks and ideally upto a month Receives: Drug: Ticagrelor |
| standard arm clopidogrel 75 mg qday | Active comparator | Not described Receives: Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent Thrombosis
- 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
- 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
Measured: Stent thrombosis occurring 24 hours to 30 DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start24 Aug 2023
- Primary completion3 Mar 2024
- Study completion16 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for STEMI - ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 1727
- Masking
- None (open label)
- Enrolment
- 1,727 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiovascular Diseases, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Abdul Hakeem, National Institute of Cardiovascular Diseases, Pakistan
- Investigators
- Abdul Hakeem, MD, Principal investigator, National Institute of Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667349
- Sponsor's protocol ID
- NICVD IRB-40/2023
- Acronym
- TISSARA
- Status last verified
- Oct 2024
- First submitted
- 28 Sep 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 35586746Schulz 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.
PubMed 19596658Dubey 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.
PubMed 28648416
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06667349
- Acronym / sponsor ID
- TISSARA / NICVD IRB-40/2023
- Keywords
- clinical trial, STEMI, stent thrombosis, ticagrelor, clopidogrel, health care intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,727 participants (actual)
- Lead sponsor
- National Institute of Cardiovascular Diseases, PakistanUniversity, hospital or other
- Study start
- 24 Aug 2023 (actual)
- Primary completion
- 3 Mar 2024 (actual)
- Study completion
- 16 Jun 2024 (actual)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1727
| Arm | Type | Receives |
|---|---|---|
| Tiacgrelor (Tissara) 90 mg pod BID | Experimental | Drug: TicagrelorTicagrelor 90 mg bid give for atleast two weeks and ideally upto a month |
| standard arm clopidogrel 75 mg qday | Active comparator | Drug: Ticagrelor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Patients who underwent plain old balloon angioplasty (POBA) or left heart catheterization (LHC) only.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TicagrelorAlso: BrilintaTicagrelor 90 mg PO BID given for atleast two weeks following primary PCI | Drug | Tiacgrelor (Tissara) 90 mg pod BID, standard arm clopidogrel 75 mg qday |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Background: PubMed 35586746Kumar 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.
- Background: PubMed 19596658Schulz 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.
- Background: PubMed 28648416Dubey 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdul Hakeem, MD principal investigator
National Institute of Cardiovascular Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ticagrelor in people with STEMI - ST Elevation Myocardial Infarction and Stent Thrombosis, run by National Institute of Cardiovascular Diseases, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stent Thrombosis (time frame: Stent thrombosis occurring 24 hours to 30 DAYS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06667349, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.