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CompletedNCT02131103Updated Feb 2, 2016

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.

An interventional study of Percutaneous coronary intervention in ST-elevation Myocardial Infarction, sponsored by Chiang Mai University. Completed at 1 site in Thailand. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-02-02.

Sponsored by Chiang Mai University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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. 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:

  1. The patients who received the percutaneous coronary intervention after fibrinolysis
  2. Adult patients with age more than 18 years old
  3. GRACE risk score less than 155 (low-intermediate risk)

Exclusion criteria:

  1. The patients who received primary PCI or rescue PCI
  2. The patients who had the previous history of coronary-artery bypass surgery
  3. 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.

02

Conditions studied

  • ST-elevation Myocardial Infarction

Keywords

  • Pharmacoinvasive strategy
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 130 is below the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Chiang Mai University is the lead sponsor of 116 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. The patients who received the percutaneous coronary intervention after fibrinolysis
  2. Adult patients with age more than 18 years old
  3. GRACE risk score less than 155 (low-intermediate risk)

Exclusion criteria

Exclusion Criteria:

  1. The patients who received primary PCI or rescue PCI
  2. The patients who had the previous history of coronary-artery bypass surgery
  3. The high risk patients (such as cardiogenic shock, complete heart block, GRACE ≥155)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
130 participants (actual)

Study arms

  • Active comparator
    Early ( < 24hr)

    Early percutaneous coronary intervention means performed coronary intervention between 3-24 hours after successful fibrinolytic therapy.

    Other: Percutaneous coronary intervention

  • Active comparator
    Delay ( > 24 hours)

    Delay percutaneous coronary intervention means received coronary intervention \>24 hours to 2 weeks after successfully fibrinolytic therapy.

    Other: Percutaneous coronary intervention

  • Active comparator
    Early

    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.

    Other: Percutaneous coronary intervention

Interventions

  • OtherPercutaneous coronary intervention

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

07

Study locations

1 site
  • Chiang Mai University
    Amphoe Muang Chiang Mai, Chiang Mai 50200, Thailand
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02131103
Lead sponsor
Chiang Mai University
Responsible party
Yotsawee Chotechuang (Chiang Mai University, Chiang Mai University) — Principal investigator
First posted
May 6, 2014
Start date
Jan 2014
Primary completion
Jan 2016
Completion
Jan 2016
Last update
Feb 2, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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