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.

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Chiang Mai University
Sponsor:
Information provided by (Responsible Party):
Yotsawee Chotechuang, Chiang Mai University
ClinicalTrials.gov Identifier:
NCT02131103
First received: May 3, 2014
Last updated: May 6, 2014
Last verified: May 2014
  Purpose
  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.

Condition Intervention
ST-elevation Myocardial Infarction
Other: Percutaneous coronary intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Chiang Mai University:

Primary Outcome Measures:
  • composite outcomes(included of death, re-infarction, and recurrent ischemia), re-hospitalized with ACS, and worsening heart failure. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 120
Study Start Date: December 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02131103

Locations
Thailand
Chiang Mai University Recruiting
Amphoe Muang Chiang Mai, Chiang Mai, Thailand, 50200
Contact: Yotsawee Chotechuang, MD    +66 54 237400 to 8721    yosnarak@hotmail.com   
Contact: Arintaya Prominthikul, MD    +66 53 946713      
Principal Investigator: Yotsawee Chotechuang, MD         
Sponsors and Collaborators
Chiang Mai University
  More Information

No publications provided

Responsible Party: Yotsawee Chotechuang, Chiang Mai University
ClinicalTrials.gov Identifier: NCT02131103     History of Changes
Other Study ID Numbers: COM-2556-01631
Study First Received: May 3, 2014
Last Updated: May 6, 2014
Health Authority: Thailand: Ethical Committee

Keywords provided by Chiang Mai University:
Pharmacoinvasive strategy

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 30, 2014