Acute Coronary SyndromePhase 4NCT02792712
Ticagrelor Versus Clopidogrel in Myocardial Salvage in Patients With STEMI Undergoing Primary PCI
A Phase 4 study testing Ticagrelor and Clopidogrel in people with Acute Coronary Syndrome, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Therefore, in this study, we try to evaluate the impact of clopidogrel loading dose 300mg vs. ticagrelor 180 mg on myocardial injury as measured by contrast-enhanced magnetic resonance imaging (CE-MRI) in STEMI patients undergoing primary PCI. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Ticagrelor and Clopidogrel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2016to Jan 2018
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of informed consent prior to any study specific procedures
- Adult patients aged 20 years or older
- STEMI within 12 hours of onset, defined as:presence of chest pain for >30 minutes and <12 hours after symptom onset; ST-segment elevation >1 mm in ≥2 contiguous leads or presumably a new-onset left bundle-branch block on electrocardiogram.
- STEMI patients planned for PPCI
Who cannot join
- STEMI > 12 h of onset
- History of renal dysfunction requiring dialysis
- Evidence of malignant diseases
- Unwillingness to give out consent
- Contraindicated for ticagrelor or clopidogrel
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Teipei Veterans General Hospital
Taipei, 112
Tao-Cheng Wu, MD, PhD, +886-2-28712121 ext. 3655, dcwu@vghtpe.gov.tw
Tao-Cheng Wu, MD, PhD
About this study
Official title: Ticagrelor Versus Clopidogrel in Myocardial Salvage in Patients With ST-elevation Myocardial Infarction (STEMI) Undergoing Primary Percutaneous Coronary Intervention: A Magnetic Resonance Imaging Study (TIGER Study)
Therefore, in this study, we try to evaluate the impact of clopidogrel loading dose 300mg vs. ticagrelor 180 mg on myocardial injury as measured by contrast-enhanced magnetic resonance imaging (CE-MRI) in STEMI patients undergoing primary PCI.
Read the detailed description
All STEMI patients will be loaded with dual oral antiplatelet therapy of 300 mg aspirin combined with either 300 mg clopidogrel or 180 mg ticagrelor before PCI, followed by maintenance dose of 100 mg aspirin plus 75 mg clopidogrel QD or 90 mg ticagrelor BID. The duty interventional cardiologists will be responsible for patient randomization based on a pre-defined randomization chart. As it is a usual practice in Taiwan for door-to-balloon time to be within 90 minutes, we hence do not expect any impact on study results due to D2B time variation.
All STEMI patients will receive loading dose of dual oral antiplatelet therapy with 300 mg aspirin combined with either 300 mg clopidogrel or 180 mg ticagrelor before PCI, followed by maintenance dose of 100 mg aspirin plus 75 mg clopidogrel QD or 90 mg ticagrelor BID.
The primary variable is to compare myocardial salvage index (in %) as assessed by CE-MRI between 300-mg clopidogrel group and ticargrelor group. Enzymatic infarct size will also be assessed, and two methods will be used to decide that. The first is cardiac troponinI 72 hours after pain onset , while the other is peak CK level after pain onset. Sampling timing of CK will be judged by the caring physicians.
The secondary objectives include: myocardial infarct size (% of LV mass), the extent of MVO, the number of segments with >75% of infarct transmurality.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Ticagrelor, Clopidogrel
- Keywords
- Acute myocardial infarction, Antiplatelet agents, Magnetic resonance imaging (MRI)
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Ticagrelor 180 mg LD，then 90 mg BID
ClopidogrelDrug
Clopidogrel 300 mg LD，then 75 mg QD
| Study group | Role | What they receive |
|---|---|---|
| STEMI_MRI_Ticagrelor | Experimental | A Magnetic Resonance Imaging Study in myocardial salvage in patients with ST-Elevation myocardial infarction (STEMI) undergoing pRimary percutaneous coronary intervention - Ticagrelor Arm Receives: Drug: Ticagrelor |
| STEMI_MRI_Clopidogrel | Active comparator | A Magnetic Resonance Imaging Study in myocardial salvage in patients with ST-Elevation myocardial infarction (STEMI) undergoing pRimary percutaneous coronary intervention - Clopidogrel Arm Receives: Drug: Clopidogrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare myocardial infarct size (myocardial salvage index %) as assessed by CE-MRI between 300-mg clopidogrel group and 180-mg ticargrelor group
Measured: 4-10 days after the index event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, vghtpe user, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792712
- Sponsor's protocol ID
- 2014-09-003A
- Status last verified
- Jun 2016
- First submitted
- 18 May 2016
- Last updated
- 7 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ticagrelor Versus Clopidogrel in Myocardial Salvage in Patients With ST-elevation Myocardial Infarction (STEMI) Undergoing Primary Percutaneous Coronary Intervention: A Magnetic Resonance Imaging Study (TIGER Study)
- ClinicalTrials.gov ID
- NCT02792712
- Acronym / sponsor ID
- 2014-09-003A
- Conditions
- Acute Coronary Syndrome
- Keywords
- Acute myocardial infarction, Antiplatelet agents, Magnetic resonance imaging (MRI)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Jan 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 7 Jun 2016 (estimated)
- 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.
Therefore, in this study, we try to evaluate the impact of clopidogrel loading dose 300mg vs. ticagrelor 180 mg on myocardial injury as measured by contrast-enhanced magnetic resonance imaging (CE-MRI) in STEMI patients undergoing primary PCI.
Detailed description
All STEMI patients will be loaded with dual oral antiplatelet therapy of 300 mg aspirin combined with either 300 mg clopidogrel or 180 mg ticagrelor before PCI, followed by maintenance dose of 100 mg aspirin plus 75 mg clopidogrel QD or 90 mg ticagrelor BID. The duty interventional cardiologists will be responsible for patient randomization based on a pre-defined randomization chart. As it is a usual practice in Taiwan for door-to-balloon time to be within 90 minutes, we hence do not expect any impact on study results due to D2B time variation.
All STEMI patients will receive loading dose of dual oral antiplatelet therapy with 300 mg aspirin combined with either 300 mg clopidogrel or 180 mg ticagrelor before PCI, followed by maintenance dose of 100 mg aspirin plus 75 mg clopidogrel QD or 90 mg ticagrelor BID.
The primary variable is to compare myocardial salvage index (in %) as assessed by CE-MRI between 300-mg clopidogrel group and ticargrelor group. Enzymatic infarct size will also be assessed, and two methods will be used to decide that. The first is cardiac troponinI 72 hours after pain onset , while the other is peak CK level after pain onset. Sampling timing of CK will be judged by the caring physicians.
The secondary objectives include: myocardial infarct size (% of LV mass), the extent of MVO, the number of segments with >75% of infarct transmurality.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEMI_MRI_Ticagrelor | Experimental | Drug: TicagrelorA Magnetic Resonance Imaging Study in myocardial salvage in patients with ST-Elevation myocardial infarction (STEMI) undergoing pRimary percutaneous coronary intervention - Ticagrelor Arm |
| STEMI_MRI_Clopidogrel | Active comparator | Drug: ClopidogrelA Magnetic Resonance Imaging Study in myocardial salvage in patients with ST-Elevation myocardial infarction (STEMI) undergoing pRimary percutaneous coronary intervention - Clopidogrel Arm |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of informed consent prior to any study specific procedures
- Adult patients aged 20 years or older
- STEMI within 12 hours of onset, defined as:presence of chest pain for >30 minutes and <12 hours after symptom onset; ST-segment elevation >1 mm in ≥2 contiguous leads or presumably a new-onset left bundle-branch block on electrocardiogram.
- STEMI patients planned for PPCI
Key exclusion criteria (5 listed)
- STEMI > 12 h of onset
- History of renal dysfunction requiring dialysis
- Evidence of malignant diseases
- Unwillingness to give out consent
- Contraindicated for ticagrelor or clopidogrel
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 |
|---|---|---|
| TicagrelorTicagrelor 180 mg LD，then 90 mg BID | Drug | STEMI_MRI_Ticagrelor |
| ClopidogrelClopidogrel 300 mg LD，then 75 mg QD | Drug | STEMI_MRI_Clopidogrel |
Primary outcome
Compare myocardial infarct size (myocardial salvage index %) as assessed by CE-MRI between 300-mg clopidogrel group and 180-mg ticargrelor group
Time frame: 4-10 days after the index event
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2016.
- Individual participant dataSharing planned: No
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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.
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 and Clopidogrel in people with Acute Coronary Syndrome, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Jun 2016. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tao-Cheng Wu, MD, PhD. ((02)28712121 ext. 3793, dcwu@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare myocardial infarct size (myocardial salvage index %) as assessed by CE-MRI between 300-mg clopidogrel group and 180-mg ticargrelor group (time frame: 4-10 days after the index event). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2016.