Optimal Coronary Flow After PCI for Myocardial Infarction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2022-12-31

Brief Summary

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In this study the investigators test the hypothesis that alteplase given intra coronary after PCI reduce infarct size in patients with ST-elevation myocardial infarction(STEMI) and impaired microvascular function defined as a value of index of microvascular resistance (IMR) \>30.

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Detailed Description

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After coronary stenting, index of microvascular resistance (IMR) will be measured invasively. Patients with IMR \>30 will be randomised to 20 mg alteplase or placebo (NaCl) administered in the culprit vessel through a microcatheter. Magnet resonance imaging (MRI) of the myocardium will be performed early (2-6 days) and late (3 months) to estimate the primary endpoint (infarct size).

10 non-randomised patients, with IMR \<30, will undergo the same follow-up as the randomised patients.

Clinical events for all randomised and non-randomised patients will be collected from Swedish national registries and by telephone at 3 and 12 months.

Conditions

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ST-segment Elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Alteplase

40 patients: 4-5 minutes of infusion of 10 ml of alteplase 2mg/ml in culprit vessel

Group Type EXPERIMENTAL

alteplase

Intervention Type DRUG

Placebo

40 patients: 4-5 minutes of infusion of 10 ml of NaCl in culprit vessel

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Observational

10 patients with IMR \<30 will undergo the same follow-up as the randomised patients

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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alteplase

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Actilyse® NaCl

Eligibility Criteria

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Inclusion Criteria

1. Oral and signed informed consent
2. Males and females 18 - 85 years of age
3. Diagnosis of ST-elevation myocardial infarction (STEMI) including occlusion of culprit vessel on angiography
4. Onset of continuous symptoms within 12 hours
5. Have undergone PCI of culprit vessel
6. Subjects are willing to comply with scheduled visits and tests and are able and willing to provide informed consent

Exclusion Criteria

1. Previously known ejection fraction \<30%
2. Previous PCI in the culprit vessel
3. Chronic total occlusion in major vessel
4. Any history of bleeding diathesis, known coagulopathy, or will refuse blood transfusions
5. Recent history or known platelet count \<100.000 cells/mm3 or Hbg \< 10 g/dL
6. Known reduced kidney function with estimated glomerular filtration rate (GFR) \<30 ml/min/1.73m2.
7. Previous hemorrhagic stroke
8. Ongoing oral anticoagulation treatment
9. Severe asthma requiring daily treatment
10. Any mechanical complication (e.g. ventricular septal defect, papillary muscle rupture, cardiac tamponade)
11. Atrioventricular block grade III
12. Known inability to undergo MRI investigation

Permanent pacemaker
* Pronounced claustrophobia
13. Known intolerance to study drug
14. Known intolerance to adenosine
15. Pregnancy
16. Participation in another investigational drug study
17. Previous randomization in the OPTIMAL-PCI trial

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No