Evaluation of Statin Mechanism Preventing Cardiovascular Disease by Post-hoc Analysis of Treating to New Targets Study
TNTpost-hoc
Statin Intensity, Achieved LDL Cholesterol, and Cardiovascular Outcome in Statin Therapy in Patients With Coronary Artery Disease (Post-hoc Study of TNT Trial)
1 other identifier
interventional
10,001
0 countries
N/A
Brief Summary
Epidemiological studies have shown that serum cholesterol level is correlated with Cardiovascular Disease (CVD) risk, and that Cardiovascular Disease (CVD) risk increases with increasing LDL cholesterol levels. Fortunately, it has been confirmed that cholesterol-lowering therapy is effective in preventing Cardiovascular Disease (CVD), and cholesterol lowering with statin therapy is a primary strategy in the prevention of Cardiovascular Disease (CVD). Despite the fact that statins reduce both LDL cholesterol and future cardiovascular outcome, the association of statin intensity and the achieved level of LDL cholesterol with cardiovascular outcome has not been fully elucidated, because statins have pleiotropic effect as well as LDL lowering effect. The effect of statin on future Cardiovascular (CV) outcome seems to be more associated with statin intensity relating pleiotropic effects rather than with achieved LDL cholesterol level, because LDL-lowering by inhibition of hepatic cholesterol synthesis is linked to reciprocal increment of cholesterol absorption from the intestine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 cardiovascular-diseases
Started Apr 1998
Longer than P75 for phase_4 cardiovascular-diseases
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 3, 1998
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 28, 2017
CompletedFirst Posted
Study publicly available on registry
March 8, 2017
CompletedMay 1, 2017
April 1, 2017
9.1 years
February 28, 2017
April 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Relation between achieved LDL cholesterol level and the occurence of a first major CV event after adjustment of statin intensity
The effect of the achieved LDL cholesterol level on CV outcomes after adjustment of statin intensity. Definition of a first major cardiovascular event: death from CHD, nonfatal non-procedure-related myocardial infarction, resuscitation after cardiac arrest, or fatal or nonfatal stroke
Up to 6 years
Secondary Outcomes (2)
The Relation between statin intensity and the occurence of a first major CV event after adjustment of achieved LDL cholesterol level
Up to 6 years
The Relation between th amount of LDL cholesterol level and the occurence of a first major CV event after adjustment of statin intensity
Up to 6 years
Study Arms (2)
Atorvastatin 10mg
ACTIVE COMPARATOR5006 patients received continuous medication with atorvastatin 10mg/day after run-in period.
Atorvastatin 80mg
EXPERIMENTAL4995 patients received medication with atorvastatin 80mg/day after run-in period.
Interventions
Eligibility Criteria
You may qualify if:
- Men and women 35 to 75 years of age
- Clinically evident Coronary Heart Disease (CHD), defined by one or more of the following:
- previous myocardial infarction,
- previous or current angina with objective evidence of CHD,
- a history of coronary revascularization.
You may not qualify if:
- hypersensitivity to statins
- active liver disease or hepatic dysfunction defined as alanine aminotransferase or aspartate aminotransferase \>1.5 times the upper limit of normal
- women who are pregnant or breastfeeding
- patients with nephrotic syndrome
- uncontrolled diabetes mellitus
- uncontrolled hypothyroidism
- uncontrolled hypertension at the screening visit;
- a Myocardial infarction (MI), coronary revascularization procedure or severe/unstable angina within 1 month of screening
- any planned surgical procedure for the treatment of atherosclerosis
- an ejection fraction \<30%
- hemodynamically important valvular disease
- gastrointestinal disease limiting drug absorption or partial ileal bypass
- any nonskin malignancy, malignant melanoma or other survival-limiting disease
- unexplained creatine phosphokinase levels \>6 times the upper limit of normal
- concurrent therapy with long-term immunosuppressants
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Korea University Guro Hospitallead
- Pfizercollaborator
Related Publications (1)
LaRosa JC, Grundy SM, Waters DD, Shear C, Barter P, Fruchart JC, Gotto AM, Greten H, Kastelein JJ, Shepherd J, Wenger NK; Treating to New Targets (TNT) Investigators. Intensive lipid lowering with atorvastatin in patients with stable coronary disease. N Engl J Med. 2005 Apr 7;352(14):1425-35. doi: 10.1056/NEJMoa050461. Epub 2005 Mar 8.
PMID: 15755765BACKGROUND
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hong Seog Seo, MD
Korea University Guro Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double-Blind
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 28, 2017
First Posted
March 8, 2017
Study Start
April 3, 1998
Primary Completion
May 1, 2007
Study Completion
May 1, 2007
Last Updated
May 1, 2017
Record last verified: 2017-04
Data Sharing
- IPD Sharing
- Will not share