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Protective Effect of Early High Dose stATins On Cardiovascular and Renal Events in Acute Coronary Syndrome

NCT ID: NCT04087200

Last Updated: 2019-09-12

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

RECRUITING

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-01

Study Completion Date

2026-12-01

Brief Summary

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Registration of all ACS patients (STEMI and NSTEMI) admitted to the cardiology ward and scheduled for early invasive strategy. The aim is to evaluate the protective effects of early (on admission) high-dose high-potency statin therapy on early and mid-term cardiac and renal events in this subset of patients.

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Detailed Description

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Statin-naive patients and those on statin therapy with ACS who are admitted to the cardiology ward of our public (National Health Service) hospital and are scheduled for early invasive strategy receive immediately on admission, always before angiographic procedure, high-dose statin therapy. Either atorvastatin 80 mg or rosuvastatin 40 mg is administered at the discretion of the physician. During hospitalization various pertinent cardiac and renal parameters, including hematological, angiographic, clinical data are registered in a dedicated database. Clinical follow-up and hematological analysis are done 1 month after discharge. A second follow-up, either clinical or by telephone, is done 1 year after discharge.

Conditions

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Acute Coronary Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Acute coronary syndrome (ST elevation and non ST elevation)
* Early invasive strategy

Exclusion Criteria

* contraindication to statin therapy
* refusal of consent
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda USL 4 Prato

OTHER

Sponsor Role collaborator

Centro Cardiopatici Toscani

OTHER

Sponsor Role lead

Responsible Party

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Anna Toso

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cardiology Division, Prato Hospital

Prato, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Anna Toso, MD

Role: CONTACT

[email protected]
00393387982507

Mario Leoncini, MD

Role: CONTACT

[email protected]
0039-0574803738

Facility Contacts

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Anna Toso, MD

Role: primary

[email protected]
+390574434396

Mario Leoncini, MD

Role: backup

[email protected]
+390574434270

Other Identifiers

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OSS 15.161

Identifier Type: -

Identifier Source: org_study_id

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