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OpenTrials
Completed

NCT Number: NCT00327691

A Study to Determine the Degree of Additional Reduction in CV Risk in Lowering LDL Below Minimum Target Levels

The primary objective of this study is to determine the degree of additional reduction in cardiovascular risk that was accrued to patients by lowering their LDL-C beyond the currently accepted minimum target level for patients with pre-existing CHD. Secondary objectives include the safety profile of this treatment strategy, its cost-effectiveness, effect on other atherosclerotic-related events and procedures, and total mortality.

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Key information

Conditions

Cardiovascular Disease Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Accident Cerebrovascular Disorders Coronary Disease Coronary Heart Disease Heart Diseases Myocardial Ischemia Nervous System Diseases Stroke Vascular Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site, St Leonards, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Men and women age 35-75 who have evident CHD

Exclusion criteria

Known hypersensitivity to HMG CO-A reductase therapy, liver disease, evidence of secondary hyperlipidemia

Treatment and study plan

atorvastatin

Drug

Primary outcomes

  1. The primary outcome is the time to occurrence of a major

  2. cardiovascular event, defined as the composite outcome of the

  3. following clinical endpoints

  4. CHD death

  5. Non-fatal/Non-procedure related MI

  6. Resuscitated cardiac arrest or fatal/non-fatal stroke

Secondary outcomes

  1. The occurrence of the following clinical events

  2. Major coronary event (CHD death, non fatal myocardial infarction or resuscitated cardiac arrest)

  3. any coronary event (major coronary event or CABG

  4. PTCA, other revascularization procedure, procedure-related myocardial infarction, or documented angina)

  5. cerebrovascular event (fatal or non fatal stroke, TIA)

  6. peripheral vascular disease; hospitalization with primary diagnosis' of CHF

  7. any cardiovascular event (any of the above); and all-cause mortality.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

The Effect Of LDL-Cholesterol, Lowering Beyond Currently Recommended Minimum Targets On Coronary Heart Disesse (CHD) Recurrence In Patients With Pre-Existing CHD

Acronym: TNT

Important dates

Study start
1998
Study completion
2004
First posted
May 18, 2006
Registry last updated
May 3, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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