The Cardiac Benefit of Testosterone Replacement in Men With Low Testosterone Levels With Coronary Artery Disease After Successful Intervention of the Blockage or Narrowed Heart Artery
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to find out if giving the study drug, Androgel (testosterone) as
      a testosterone replacement help bring the testosterone to an acceptable level and to find out
      if it will help improve heart condition in males with coronary artery disease (CAD) following
      successful percutaneous coronary intervention.
    

Detailed description: 
      Males with coronary heart disease have lower serum levels of bioavailable testosterone than
      men of a similar age with normal coronary angiograms (English, European Heart Journal, 2000).
      Low plasma testosterone has been associated with known risk factors for CHD, including age,
      obesity, hyperinsulinemia, diabetes, and adverse lipid profile.

      Testosterone has also been shown in numerous studies to be a vasodilator. Recently,
      testosterone replacement compared with placebo, in hypogonadal men was shown to improve time
      to ischemic threshold, assessed by treadmill exercise testing at 4 and 12 weeks (Malkin,
      Heart, 2000). Prior studies had also shown a beneficial effect on exercise-induced ischemia
      in men with CAD, but not exclusively hypogonadal men (Jaffe,Br Heart J 1977; Rosano,
      Circulation, 1999; English, Circulation, 2000). In addition, this proposed study would be the
      first study to assess if the anti-anginal effects persists long term.

      This is a randomized, double-blind, placebo-controlled study to evaluate the safety and
      efficacy of testosterone supplementation in hypogonadal men with coronary artery disease
      following successful revascularization with percutaneous coronary intervention (PCI). Only
      those men who had successful coronary artery revascularization, and on stable cardiac medical
      regimen for the prior 4 weeks will be included. Eligible patients will then be randomized on
      a 2:1 basis with 50 subjects receiving 5 grams of AndroGel and 25 subjects receiving placebo
      gel.

      The men in this study who demonstrate hypogonadism represent a novel population to
      demonstrate the safety and efficacy of testosterone supplementation to improve cardiac
      function and outcomes. We hypothesize that treatment of hypogonadism in men with CAD,
      following successful PCI, will significantly improve cardiac ischemic threshold as assessed
      by cardiac stress testing. Furthermore, additional cardiac endpoints such as angina status,
      endothelial function and inflammatory serum markers will also demonstrate significant benefit
      in the testosterone treated group.
    

Intervention name(s): AndroGel 5 Grams; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Placebo (randomization will occur on a 2:1 drug to placebo). A total of 50 subjects will be randomized to receive Androgel 5 grams and 25 subjects will be randomized to receive placebo.
Androgel treatment/Placebo (after the treatment arm is assigned, subjects will be instructed to begin the study drug at 1 week post entry into the study and will continue to take the study drug for a total of 6 months. The study drug has to be applied to the skin once daily for 6 months.; Placebo (randomization will occur on a 2:1 drug to placebo). A total of 50 subjects will be randomized to receive Androgel 5 grams and 25 subjects will be randomized to receive placebo.
Androgel treatment/Placebo (after the treatment arm is assigned, subjects will be instructed to begin the study drug at 1 week post entry into the study and will continue to take the study drug for a total of 6 months. The study drug has to be applied to the skin once daily for 6 months.
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hypogonadal; coronary artery disease; percutaneous coronary intervention (PCI)