Clinical Trial: A Multi-centric Study to Assess the Efficacy of Sigmart in Subjects With Recurrent Angina After Coronary Revascularization

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A Clinical Trial to Assess the Efficacy of Sigmart in Patients With Recurrent Angina After Coronary Revascularization

Brief Summary: The multi-centric, open label, single arm and self controlled study is planned to assess the efficacy of orally administered Sigmart in subjects with recurrent angina after coronary revascularization. The primary objective of this study is to demonstrate that orally administered Sigmart can improve the major Exercise Tolerance Test (ETT) result in recurrent angina subjects.

Detailed Summary:
Sponsor: Merck KGaA

Current Primary Outcome: Time to 1 mm ST-depression [ Time Frame: until day 28 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Exercise tolerance test parameters [ Time Frame: until day 28 ]

  Exercise Tolerance Test (ETT) parameters include:

  • Total exercise time
  • Time to onset of chest pain using ETT
  • Maximum ST-depression
  • SBP × HR (Pressure Rate Product)
  • Metabolic Equivalents (METs)
  • ETT grade and Score
• Consumption of nitroglycerine (NTG). [ Time Frame: until day 28 ]
  Weekly assessment of NTG consumption until visit 4 (day 28)
• Adverse events [ Time Frame: until day 28 ]
  The incidence of adverse events (especially the incidence of headache)
• Compliance [ Time Frame: until day 28 ]
  Compliance % ([total number of tablets taken divided by the total number of tablets to be taken] multiplied by 100)
• Number of angina attacks per week [ Time Frame: until day 28 ]
  Weekly assessment of angina attacks until day 28

Original Secondary Outcome: Same as current

Information By: Merck KGaA

Dates:
Date Received: August 18, 2010
Date Started: January 2011
Date Completion:
Last Updated: July 1, 2014
Last Verified: July 2012