Non-ST Segment Elevation Myocardial InfarctionPhase 4NCT02026219
Comparison of Clopidogrel and Ticagrelor on Microvascular Dysfunction in ST-Segment Elevation Myocardial Infarction
A Phase 4 study testing Clopidogrel and Ticagrelor in people with Non-ST Segment Elevation Myocardial Infarction and ST Segment Elevation Myocardial Infarction, run by Inha University Hospital at 1 site in South Korea.
Trial summary
Ticagrelor is a non-thienophyridine, direct P2Y12 blocker that is more potent than clopidogrel and is associated with less interindividual variability. In the PLATO trial, it was found to be superior to clopidogrel with respect to cardiovascular outcomes and total mortality without increasing the risk of bleedings. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-ST Segment Elevation Myocardial Infarction, ST Segment Elevation Myocardial Infarction
- What is being tested?
- Clopidogrel and Ticagrelor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2013to Dec 2014
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and Females
- between the ages of 18 and 75 years
- STEMI patients treated with percutaneous coronary intervention
- Able to provide informed consent
Who cannot join
- History of stroke or transient ischemic attack
- Platelet count < 100 000/μL
- Known Bleeding Diathesis
- Hematocrit <30% or >52%
- Severe Liver Dysfunction
- Renal Insufficiency (Creatinine Clearance < 30ml/min)
- Pregnant females
- Cardiogenic shock or symptomatic hypotension or sitting SBP < 95 mmHg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Clopidogrel and Ticagrelor on Microvascular Dysfunction in Acute Coronary Syndrome Patients: The Index of MIcrocirculatory Resistance After PCI in STEMI Patients (TIME Study)
Ticagrelor is a non-thienophyridine, direct P2Y12 blocker that is more potent than clopidogrel and is associated with less interindividual variability. In the PLATO trial, it was found to be superior to clopidogrel with respect to cardiovascular outcomes and total mortality without increasing the risk of bleedings.
More potent and reversible receptor bindings are possible explanation for the superior outcomes. Beside the potent effect on inhibition of antiplatelet function, ticagrelor has previously been demonstrated to increase adenosine levels by inhibiting adenosine re-uptake in tissue level and can induce adenosine triphosphate (ATP) release from human red cells, which both stimulate vasodilation of in red blood cells.
- Conditions
- Non-ST Segment Elevation Myocardial Infarction, ST Segment Elevation Myocardial Infarction
- Being tested
- Clopidogrel, Ticagrelor
- 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.
ClopidogrelDrug
Clopidogrel 600mg loading
TicagrelorDrug
Ticagrelor 180mg loading
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel | Experimental | Clopidogrel 600mg loading Receives: Drug: Clopidogrel |
| Ticagrelor | Experimental | Ticagrelor 180mg loading Receives: Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Index of microcirculatory resistance (IMR) measured after successful coronary intervention
Measured: IMR will be immediately assessed after successful PCI patients within 48hr from admission
Secondary outcomes (1)
wall motion score index on three month later TTE from index PCI
Measured: TTE will be assessed in all enrolled patients 3 month later from index PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2014 (estimated)
- Study startOct 2013
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-ST Segment 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inha University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026219
- Sponsor's protocol ID
- IUH-IRB-13-2256
- Status last verified
- Sep 2015
- First submitted
- 24 Dec 2013
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Park SD, Baek YS, Woo SI, Kim SH, Shin SH, Kim DH, Kwan J, Park KS. Comparing the effect of clopidogrel versus ticagrelor on coronary microvascular dysfunction in acute coronary syndrome patients (TIME trial): study protocol for a randomized controlled trial. Trials. 2014 May 1;15:151. doi: 10.1186/1745-6215-15-151.
PubMed 24885437
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clopidogrel and Ticagrelor on Microvascular Dysfunction in Acute Coronary Syndrome Patients: The Index of MIcrocirculatory Resistance After PCI in STEMI Patients (TIME Study)
- ClinicalTrials.gov ID
- NCT02026219
- Acronym / sponsor ID
- IUH-IRB-13-2256
- Conditions
- Non-ST Segment Elevation Myocardial Infarction, ST Segment Elevation Myocardial Infarction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Inha University HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 1 Jan 2014 (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.
Ticagrelor is a non-thienophyridine, direct P2Y12 blocker that is more potent than clopidogrel and is associated with less interindividual variability. In the PLATO trial, it was found to be superior to clopidogrel with respect to cardiovascular outcomes and total mortality without increasing the risk of bleedings.
More potent and reversible receptor bindings are possible explanation for the superior outcomes. Beside the potent effect on inhibition of antiplatelet function, ticagrelor has previously been demonstrated to increase adenosine levels by inhibiting adenosine re-uptake in tissue level and can induce adenosine triphosphate (ATP) release from human red cells, which both stimulate vasodilation of in red blood cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel | Experimental | Drug: ClopidogrelClopidogrel 600mg loading |
| Ticagrelor | Experimental | Drug: TicagrelorTicagrelor 180mg loading |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (8 listed)
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 |
|---|---|---|
| ClopidogrelClopidogrel 600mg loading | Drug | Clopidogrel |
| TicagrelorTicagrelor 180mg loading | Drug | Ticagrelor |
Primary outcome
Index of microcirculatory resistance (IMR) measured after successful coronary intervention
Time frame: IMR will be immediately assessed after successful PCI patients within 48hr from admission
1 secondary outcome
wall motion score index on three month later TTE from index PCI
Time frame: TTE will be assessed in all enrolled patients 3 month later from index PCI
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 1 Oct 2015.
- Derived from this study: PubMed 24885437Park SD, Baek YS, Woo SI, Kim SH, Shin SH, Kim DH, Kwan J, Park KS. Comparing the effect of clopidogrel versus ticagrelor on coronary microvascular dysfunction in acute coronary syndrome patients (TIME trial): study protocol for a randomized controlled trial. Trials. 2014 May 1;15:151. doi: 10.1186/1745-6215-15-151.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Clopidogrel and Ticagrelor in people with Non-ST Segment Elevation Myocardial Infarction and ST Segment Elevation Myocardial Infarction, run by Inha University Hospital at 1 site in South Korea.
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 8 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 1 Oct 2015. 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 South Korea. 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?
Index of microcirculatory resistance (IMR) measured after successful coronary intervention (time frame: IMR will be immediately assessed after successful PCI patients within 48hr from admission). 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 NCT02026219, which also lists 1 linked publication.
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 1 Oct 2015.