Trials / Withdrawn
WithdrawnNCT04303377
Early Treatment With Evolocumab in Patients With ST-elevation Myocardial Infarction
Early Treatment With evOlocumab in Patients With sT-elevation Myocardial Infarction Undergoing Primary pCi (ExOTIC Study)
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, multi-centre, open label, randomised study of Phase II that enrolls patients hospitalized with a diagnosis of ST-elevation myocardial infarction (STEMI), comparing Evolocumab versus Standard of Care.
Detailed description
Primary objective of the study is to assess whether early evolocumab administration reduces infarct size in patients with STEMI undergoing primary PCI. At least 150 patients will be enrolled to investigate the efficacy and safety of evolocumab administration in the acute phase of STEMI. Patients will be followed for 1 year after the enrollment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Evolocumab | Evolocumab 140 mg every 2 weeks plus Standard of Care, including optimal lipid lowering treatment (high dose of statin ± ezetimibe) |
Timeline
- Start date
- 2019-11-18
- Primary completion
- 2020-01-02
- Completion
- 2020-07-24
- First posted
- 2020-03-11
- Last updated
- 2024-11-21
Locations
1 site across 1 country: Italy
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04303377. Inclusion in this directory is not an endorsement.