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.

January 30, 2016 updated by: Yotsawee Chotechuang, Chiang Mai University
  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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Chiang Mai
      • Amphoe Muang Chiang Mai, Chiang Mai, Thailand, 50200
        • Chiang Mai University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Early ( < 24hr)
Early percutaneous coronary intervention means performed coronary intervention between 3-24 hours after successful fibrinolytic therapy.
Other: Percutaneous 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.
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

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.
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiang Mai University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

May 3, 2014

First Submitted That Met QC Criteria

May 5, 2014

First Posted (Estimate)

May 6, 2014

Study Record Updates

Last Update Posted (Estimate)

February 2, 2016

Last Update Submitted That Met QC Criteria

January 30, 2016

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COM-2556-01631

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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