EUCTR2021-000573-80-FR
Active, not recruiting
Phase 1
Acute Myocardial infarction Upbound to percutaneous coronary intervention, immediately (STEMI) or in the Next three Days (NSTEMI), and randomized to Subcutaneous Evolocumab or Normal strategies to reach guidelines LDL objectives in the real-world- The AMUNDSEN-real study
APHP DRCI0 sitesMarch 10, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- APHP DRCI
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Male or female
- •\-Diagnosis of STEMI defined as:
- •osymptoms of acute MI of at least 30 min AND
- •owithin the previous 24 hours with new persistent ST\-segment elevation \=1 mm in \=2 continuous ECG leads AND
- •oan indication for primary PCI AND
- •o\> 55 years
- •\-Diagnosis of NSTEMI defined as
- •oa history of chest discomfort or ischemic symptoms of \=10 minutes duration at rest \=48 hours prior to entry into the study with no evidence of persistent ST\-segment elevation and with an elevated troponin (\= the upper limit of normal according to local laboratory norms), AND
- •oindication for a coronary angiogram within 72hrs AND
- •oindication for PCI AND
Exclusion Criteria
- •Participant presenting with any of the following will not be included in the study:
- •\-Fibrinolysis treatment
- •\-Planned CABG
- •\-Ongoing hemodynamic instability defined as any of the following:
- •oKillip Class III or IV
- •oSustained and/or symptomatic hypotension (systolic blood pressure \< 80 mm Hg)
- •oKnown left ventricular ejection fraction \< 30%
- •\-Evidence of severe hepatobiliary disease: current active hepatic dysfunction or active biliary obstruction, decompensated cirrhosis or infectious/inflammatory hepatitis
- •\-Active malignancy
- •\-A comorbid condition with an estimated life expectancy of \= 12 months
Outcomes
Primary Outcomes
Not specified
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