ST-elevation Myocardial InfarctionNCT02131103
The Short- and Long Term Outcomes of Early Routine PCI With the Standard Treatment in Low-intermediate Risk ST-elevation Myocardial Infarction Patients Who Successfully Fibrinolysis.
A study testing Percutaneous coronary intervention in people with ST-elevation Myocardial Infarction, run by Chiang Mai University at 1 site in Thailand.
Trial summary
1. Objective: To evaluate short- and long-term in the STEMI patients who successfully thrombolysis with early routine and delay percutaneous coronary intervention in low-intermediate risk patients. 2. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ST-elevation Myocardial Infarction
- What is being tested?
- Percutaneous coronary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2014to Jan 2016
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients who received the percutaneous coronary intervention after fibrinolysis
- Adult patients with age more than 18 years old
- GRACE risk score less than 155 (low-intermediate risk)
Who cannot join
- The patients who received primary PCI or rescue PCI
- The patients who had the previous history of coronary-artery bypass surgery
- The high risk patients (such as cardiogenic shock, complete heart block, GRACE ≥155)
Trial locations and contacts
1 site in 1 country.
About this study
- Objective: To evaluate short- and long-term in the STEMI patients who successfully thrombolysis with early routine and delay percutaneous coronary intervention in low-intermediate risk patients.
- Educational/ application advantages: To evaluate the time of early and delay PCI after received fibrinolysis had an effect to the short- and long-term clinical outcomes in low- intermediate GRACE risk score patients. No available of randomized controlled study in these group of the patients.
Read the detailed description
1.Research design: Intervention trial 1.1 Study domain: STEMI patients who will receive the fibrinolysis for reperfusion therapy 1.2 Target population: STEMI patients who will receive the percutaneous coronary intervention after fibrinolysis in Lampang Regional hospital and Maharaj Nakorn Chiang Mai hospital.
1.3 Study population: STEMI patients who will receive the percutaneous coronary intervention after fibrinolysis during the year of 2013-2014 at Lampang Regional hospital and Maharaj Nakorn Chiang Mai hospital
Inclusion criteria:
- The patients who received the percutaneous coronary intervention after fibrinolysis
- Adult patients with age more than 18 years old
- GRACE risk score less than 155 (low-intermediate risk)
Exclusion criteria:
- The patients who received primary PCI or rescue PCI
- The patients who had the previous history of coronary-artery bypass surgery
- The high risk patients (such as cardiogenic shock, complete heart block, GRACE ≥155)
1.4 Occurrence relation Y (Composite outcomes) = f (Treatment early vs. delay | confounders)
1.5 Setting: The study will be conducted in Lampang Regional hospital and Maharaj Nakorn Chiang Mai hospital.
1.6 Determinant (x): Time to percutaneous coronary intervention (early vs. delayed).
1.7 Events (y): composite outcomes (included of death, re-infarction, and recurrent ischemia), re-hospitalized with ACS, and worsening heart failure.
- Conditions
- ST-elevation Myocardial Infarction
- Being tested
- Percutaneous coronary intervention
- Keywords
- Pharmacoinvasive strategy
- 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.
Percutaneous coronary interventionOther
All patients received fibrinolysis, aspirin 300 mg and clopidogrel (300 mg for participants 75 years of age or younger or 75 mg for participants older than 75 years of age). Patients older than 75 years of age did not receive enoxaparin.
Patients will be randomly assigned to either the group that received routine early PCI (hereinafter termed the early-PCI group) or the group that received standard treatment (PCI performed after 24-72 hours of successfully fibrinolysis). Randomized will perform within 24 hours after successful fibrinolytic therapy. PCI will be performed when persistent occlusion or substantial stenosis of the infarct-related artery (either stenosis of 70% or more of the diameter of the artery or stenosis of 50-70% with thrombus, ulceration, or spontaneous dissection) was present. In case of multivessel disease, only culprit lesion will be correct.
| Study group | Role | What they receive |
|---|---|---|
| Early ( < 24hr) | Active comparator | Early percutaneous coronary intervention means performed coronary intervention between 3-24 hours after successful fibrinolytic therapy. Receives: Other: Percutaneous coronary intervention |
| Delay ( > 24 hours) | Active comparator | Delay percutaneous coronary intervention means received coronary intervention >24 hours to 2 weeks after successfully fibrinolytic therapy. Receives: Other: Percutaneous coronary intervention |
| Early | Active comparator | We randomized the patients into two groups early (≤ 24 hours) and delay group (> 24 hours) All patients received fibrinolysis, aspirin 300 mg and clopidogrel (300 mg for participants 75 years of age or younger or 75 mg for participants older than 75 years of age). Patients older than 75 years of age did not receive enoxaparin.
Patients will be randomly assigned to either the group that received routine early PCI (hereinafter termed the early-PCI group) or the group that received standard treatment (PCI performed after 24-72 hours of successfully fibrinolysis). Randomized will perform within 24 hours after successful fibrinolytic therapy. PCI will be performed when persistent occlusion or substantial stenosis of the infarct-related artery (either stenosis of 70% or more of the diameter of the artery or stenosis of 50-70% with thrombus, ulceration, or spontaneous dissection) was present. In case of multivessel disease, only culprit lesion will be correct. Receives: Other: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite outcomes(included of death, re-infarction, and recurrent ischemia), re-hospitalized with ACS, and worsening heart failure.
Composite outcomes included of death, re-infarction, recurrent ischemia, re-hospitalized with ACS and worsening heart failure at 30 days for short- and 6 months for long-term outcomes.
Death was defined as all cause of death (cardiac and non-cardiac cause). Recurrent MI 'Incident MI' is defined as the individual's first MI. Re-infarction The term of 're-infarction' is used for an acute MI that occurs within 28 days of an incident- or recurrent MI.
Re-hospitalized with ACS was defined as re-admission after discharge from hospital with acute coronary syndrome composed with clinical chest pain, rising of cardiac enzymes and dynamic ST-segment change.
Re-hospitalized with heart failure was defined as re-admission after discharge from hospital with clinical decompensated heart failure.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2016
- Study completionJan 2016
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yotsawee Chotechuang, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131103
- Sponsor's protocol ID
- COM-2556-01631
- Status last verified
- May 2014
- First submitted
- 3 May 2014
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chotechuang Y, Phrommintikul A, Kuanprasert S, Muenpa R, Patumanond J, Chaichuen T, Sukonthasarn A. Cardiovascular outcomes of early versus delayed coronary intervention in low to intermediate-risk patients with STEMI in Thailand: a randomised trial. Heart Asia. 2019 Jun 12;11(2):e011201. doi: 10.1136/heartasia-2019-011201. eCollection 2019.
PubMed 31275432
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Short- and Long Term Outcomes of Early Routine PCI With the Standard Treatment in Low-intermediate Risk ST-elevation Myocardial Infarction Patients Who Successfully Fibrinolysis.
- ClinicalTrials.gov ID
- NCT02131103
- Acronym / sponsor ID
- COM-2556-01631
- Conditions
- ST-elevation Myocardial Infarction
- Keywords
- Pharmacoinvasive strategy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 6 May 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.
- Objective: To evaluate short- and long-term in the STEMI patients who successfully thrombolysis with early routine and delay percutaneous coronary intervention in low-intermediate risk patients.
- Educational/ application advantages: To evaluate the time of early and delay PCI after received fibrinolysis had an effect to the short- and long-term clinical outcomes in low- intermediate GRACE risk score patients. No available of randomized controlled study in these group of the patients.
Detailed description
1.Research design: Intervention trial 1.1 Study domain: STEMI patients who will receive the fibrinolysis for reperfusion therapy 1.2 Target population: STEMI patients who will receive the percutaneous coronary intervention after fibrinolysis in Lampang Regional hospital and Maharaj Nakorn Chiang Mai hospital.
1.3 Study population: STEMI patients who will receive the percutaneous coronary intervention after fibrinolysis during the year of 2013-2014 at Lampang Regional hospital and Maharaj Nakorn Chiang Mai hospital
Inclusion criteria:
- The patients who received the percutaneous coronary intervention after fibrinolysis
- Adult patients with age more than 18 years old
- GRACE risk score less than 155 (low-intermediate risk)
Exclusion criteria:
- The patients who received primary PCI or rescue PCI
- The patients who had the previous history of coronary-artery bypass surgery
- The high risk patients (such as cardiogenic shock, complete heart block, GRACE ≥155)
1.4 Occurrence relation Y (Composite outcomes) = f (Treatment early vs. delay | confounders)
1.5 Setting: The study will be conducted in Lampang Regional hospital and Maharaj Nakorn Chiang Mai hospital.
1.6 Determinant (x): Time to percutaneous coronary intervention (early vs. delayed).
1.7 Events (y): composite outcomes (included of death, re-infarction, and recurrent ischemia), re-hospitalized with ACS, and worsening heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early ( < 24hr) | Active comparator | Other: Percutaneous coronary interventionEarly percutaneous coronary intervention means performed coronary intervention between 3-24 hours after successful fibrinolytic therapy. |
| Delay ( > 24 hours) | Active comparator | Other: Percutaneous coronary interventionDelay percutaneous coronary intervention means received coronary intervention >24 hours to 2 weeks after successfully fibrinolytic therapy. |
| Early | Active comparator | Other: Percutaneous coronary interventionWe randomized the patients into two groups early (≤ 24 hours) and delay group (> 24 hours) All patients received fibrinolysis, aspirin 300 mg and clopidogrel (300 mg for participants 75 years of age or younger or 75 mg for participants older than 75 years of age). Patients older than 75 years of age did not receive enoxaparin. Patients will be randomly assigned to either the group that received routine early PCI (hereinafter termed the early-PCI group) or the group that received standard treatment (PCI performed after 24-72 hours of successfully fibrinolysis). Randomized will perform within 24 hours after successful fibrinolytic therapy. PCI will be performed when persistent occlusion or substantial stenosis of the infarct-related artery (either stenosis of 70% or more of the diameter of the artery or stenosis of 50-70% with thrombus, ulceration, or spontaneous dissection) was present. In case of multivessel disease, only culprit lesion will be correct. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patients who received the percutaneous coronary intervention after fibrinolysis
- Adult patients with age more than 18 years old
- GRACE risk score less than 155 (low-intermediate risk)
Key exclusion criteria (3 listed)
- The patients who received primary PCI or rescue PCI
- The patients who had the previous history of coronary-artery bypass surgery
- The high risk patients (such as cardiogenic shock, complete heart block, GRACE ≥155)
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 |
|---|---|---|
| Percutaneous coronary interventionAll patients received fibrinolysis, aspirin 300 mg and clopidogrel (300 mg for participants 75 years of age or younger or 75 mg for participants older than 75 years of age). Patients older than 75 years of age did not receive enoxaparin. Patients will be randomly assigned to either the group that received routine early PCI (hereinafter termed the early-PCI group) or the group that received standard treatment (PCI performed after 24-72 hours of successfully fibrinolysis). Randomized will perform within 24 hours after successful fibrinolytic therapy. PCI will be performed when persistent occlusion or substantial stenosis of the infarct-related artery (either stenosis of 70% or more of the diameter of the artery or stenosis of 50-70% with thrombus, ulceration, or spontaneous dissection) was present. In case of multivessel disease, only culprit lesion will be correct. | Other | Delay ( > 24 hours), Early, Early ( < 24hr) |
Primary outcome
composite outcomes(included of death, re-infarction, and recurrent ischemia), re-hospitalized with ACS, and worsening heart failure.
Time frame: 6 months
Composite outcomes included of death, re-infarction, recurrent ischemia, re-hospitalized with ACS and worsening heart failure at 30 days for short- and 6 months for long-term outcomes. Death was defined as all cause of death (cardiac and non-cardiac cause). Recurrent MI 'Incident MI' is defined as the individual's first MI. Re-infarction The term of 're-infarction' is used for an acute MI that occurs within 28 days of an incident- or recurrent MI. Re-hospitalized with ACS was defined as re-admission after discharge from hospital with acute coronary syndrome composed with clinical chest pain, rising of cardiac enzymes and dynamic ST-segment change. Re-hospitalized with heart failure was defined as re-admission after discharge from hospital with clinical decompensated heart failure.
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 2 Feb 2016.
- Derived from this study: PubMed 31275432Chotechuang Y, Phrommintikul A, Kuanprasert S, Muenpa R, Patumanond J, Chaichuen T, Sukonthasarn A. Cardiovascular outcomes of early versus delayed coronary intervention in low to intermediate-risk patients with STEMI in Thailand: a randomised trial. Heart Asia. 2019 Jun 12;11(2):e011201. doi: 10.1136/heartasia-2019-011201. eCollection 2019.
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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 study testing Percutaneous coronary intervention in people with ST-elevation Myocardial Infarction, run by Chiang Mai University at 1 site in Thailand.
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 3 inclusion and 3 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 2 Feb 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 Thailand. 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.
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?
composite outcomes(included of death, re-infarction, and recurrent ischemia), re-hospitalized with ACS, and worsening heart failure. (time frame: 6 months). 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 NCT02131103, 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 2 Feb 2016.