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.

Chiang Mai University

Status: Completed

Conditions: ST-elevation Myocardial Infarction

Treatments: Other: Percutaneous coronary intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02131103

COM-2556-01631

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 3 patient groups

Early ( < 24hr)

Active Comparator group

Description:

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

Treatment:

Other: Percutaneous coronary intervention

Delay ( > 24 hours)

Active Comparator group

Description:

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

Treatment:

Other: Percutaneous coronary intervention

Early

Active Comparator group

Description:

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.

Treatment:

Other: Percutaneous coronary intervention