Statins Evaluation in Coronary Procedures and Revascularization Trial

NCT01448642 | Completed Phase 4 DMC

• 1 other identifier: 185/2011
• Study Type: interventional
• Target: 4,191
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether a loading dose of atorvastatin before percutaneous intervention procedures in acute coronary syndromes is effective to reduce major cardiovascular events(MACE).

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• Major Cardiovascular Events (MACE)

  All-cause mortality, nonfatal acute myocardial infarction, stroke or revascularization with either percutaneous coronary intervention or coronary artery bypass grafting

  30 days

Secondary Outcomes (10)

• Major Cardiovascular Events (MACE)

  6 months and 12 months

• All-cause mortality

  30 days, 6 months and 12 months

• Non-fatal Myocardial Infarction

  30 days, 6 months and 12 months

• Non-fatal Stroke

  30 days, 6 months and 12 months

• Revascularization

  30 days, 6 months and 12 months

Study Arms (2)

Atorvastatin

ACTIVE COMPARATOR

Drug: Atorvastatin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Atorvastatin DRUG

Atorvastatin loading dose of 80mg before PCI, reloading dose of 80mg 24 hours after PCI, and atorvastatin 40mg for 30 days

Atorvastatin

Placebo DRUG

Matching placebo before PCI and 24 hours after PCI. Atorvastatin 40mg for 30 days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute coronary syndrome patients intending to undergo percutaneous coronary intervention.

You may not qualify if:

• Younger than 18 years
• Presence of any contraindication to statin (Pregnant women, breast-feeding women or statin hypersensibility)
• Advanced hepatic disease
• Use of statins at the maximum dosage in the last 24 hours before the loading dose of the study drug
• Use of fibrate in the last 24 hours

Sponsors & Collaborators

• Hospital do Coracao: lead
• Ministry of Health, Brazil: collaborator

Study Sites (1)

Hospital do Coracao

São Paulo, São Paulo, 04005-000, Brazil

Location

Related Publications (3)

• Berwanger O, Santucci EV, de Barros E Silva PGM, Jesuino IA, Damiani LP, Barbosa LM, Santos RHN, Laranjeira LN, Egydio FM, Borges de Oliveira JA, Dall Orto FTC, Beraldo de Andrade P, Bienert IRC, Bosso CE, Mangione JA, Polanczyk CA, Sousa AGMR, Kalil RAK, Santos LM, Sposito AC, Rech RL, Sousa ACS, Baldissera F, Nascimento BR, Giraldez RRCV, Cavalcanti AB, Pereira SB, Mattos LA, Armaganijan LV, Guimaraes HP, Sousa JEMR, Alexander JH, Granger CB, Lopes RD; SECURE-PCI Investigators. Effect of Loading Dose of Atorvastatin Prior to Planned Percutaneous Coronary Intervention on Major Adverse Cardiovascular Events in Acute Coronary Syndrome: The SECURE-PCI Randomized Clinical Trial. JAMA. 2018 Apr 3;319(13):1331-1340. doi: 10.1001/jama.2018.2444.

  PMID: 29525821 RESULT

• Lopes RD, de Barros E Silva PGM, de Andrade Jesuino I, Santucci EV, Barbosa LM, Damiani LP, Nakagawa Santos RH, Laranjeira LN, Dall Orto FTC, Beraldo de Andrade P, de Castro Bienert IR, Alexander JH, Granger CB, Berwanger O. Timing of Loading Dose of Atorvastatin in Patients Undergoing Percutaneous Coronary Intervention for Acute Coronary Syndromes: Insights From the SECURE-PCI Randomized Clinical Trial. JAMA Cardiol. 2018 Nov 1;3(11):1113-1118. doi: 10.1001/jamacardio.2018.3408.

  PMID: 30264159 DERIVED

• Berwanger O, de Barros E Silva PGM, Dall Orto FTC, de Andrade PB, de Castro Bienert IR, Bosso CE, Mangione J, Polanczyk CA, Sousa A, Kalil R, de Moura Santos L, Sposito AC, Rech RL, Sousa ACS, Baldissera F, Nascimento BR, de Andrade Jesuino I, Santucci EV, Damiani LP, Laranjeira LN, Borges de Oliveira JA, Giraldez RR, Cavalcanti AB, Pereira SB, Mattos LA, Armaganijan LV, Guimaraes HP, Sousa JE, Alexander JH, Granger CB, Lopes RD. Rationale and design of the Statins Evaluation in Coronary procedUres and REvascularization: The SECURE-PCI Trial. Am Heart J. 2018 Apr;198:129-134. doi: 10.1016/j.ahj.2017.12.018. Epub 2018 Jan 8.

  PMID: 29653634 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Otavio Berwanger

  Hospital do Coracao

  STUDY CHAIR

• Renato D Lopes, MD, PhD

  Brazilian Clinical Research Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2011
• First Posted: October 7, 2011
• Study Start: April 1, 2012
• Primary Completion: November 1, 2017
• Study Completion: April 1, 2018
• Last Updated: June 17, 2019

Record last verified: 2019-06

Locations

BR (1)