Acarbose Cardiovascular Evaluation Trial (ACE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by University of Oxford.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Bayer
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT00829660
First received: January 26, 2009
Last updated: September 27, 2011
Last verified: September 2011

January 26, 2009
September 27, 2011
February 2009
July 2014   (final data collection date for primary outcome measure)
Occurrence of any of the following; Cardiovascular death, Non-fatal MI, Non-fatal stroke [ Time Frame: Follow-up for approximately 4 years until 904 adjudicated Primary Outcome Measures have been recorded ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00829660 on ClinicalTrials.gov Archive Site
  • Transition to type 2 diabetes [ Time Frame: Follow-up for approximately 4 years until 904 adjudicated Primary Outcome Measures have been recorded. ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: Follow-up for approximately 4 years until 904 adjudicated Primary Outcome Measures have been recorded. ] [ Designated as safety issue: No ]
  • Cardiovascular death, non-fatal MI, non-fatal stroke, hospitalization for heart failure or hospitalization for unstable angina. [ Time Frame: Follow-up for approximately 4 years until 904 adjudicated Primary Outcome Measures have been recorded. ] [ Designated as safety issue: No ]
  • Evidence of NAFLD [ Time Frame: Follow-up for approximately 4 years until 904 adjudicated Primary Outcome Measures have been recorded. ] [ Designated as safety issue: No ]
  • Impaired renal function [ Time Frame: Follow-up for approximately 4 years until 904 adjudicated Primary Outcome Measures have been recorded. ] [ Designated as safety issue: No ]
  • Resource use, costs and cost effectiveness [ Time Frame: Follow-up for approximately 4 years until 904 adjudicated Primary Outcome Measures have been recorded. ] [ Designated as safety issue: No ]
  • Transition to type 2 diabetes [ Time Frame: Follow-up for approximately 4 years until 904 adjudicated Primary Outcome Measures have been recorded. ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: Follow-up for approximately 4 years until 904 adjudicated Primary Outcome Measures have been recorded. ] [ Designated as safety issue: No ]
  • Cardiovascular death, non-fatal MI, non-fatal stroke, hospitalization for heart failure or hospitalization for unstable angina. [ Time Frame: Follow-up for approximately 4 years until 904 adjudicated Primary Outcome Measures have been recorded. ] [ Designated as safety issue: No ]
  • Evidence of NAFLD [ Time Frame: Follow-up for approximately 4 years until 904 adjudicated Primary Outcome Measures have been recorded. ] [ Designated as safety issue: No ]
  • Impaired renal function [ Time Frame: Follow-up for approximately 4 years until 904 adjudicated Primary Outcome Measures have been recorded. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Acarbose Cardiovascular Evaluation Trial
A Phase IV Trial to Determine Whether Reducing Post-prandial Glycaemia Can Reduce Cardiovascular-related Morbidity in Patients With Established Coronary Heart Disease or Acute Coronary Syndrome Who Have Impaired Glucose Tolerance.

The purpose of this study is to determine whether acarbose therapy can reduce cardiovascular-related morbidity and mortality in patients with impaired glucose tolerance (IGT) who have established coronary heart disease (CHD) or acute coronary syndrome (ACS). A secondary objective of the study is to determine if acarbose therapy can prevent or delay transition to type 2 diabetes mellitus (T2DM) in this patient population.

A 4-year, multi-centre, double-blind, randomised parallel-group trial to determine whether reducing post-prandial glycaemia can reduce cardiovascular-related morbidity in patients with established coronary heart disease or acute coronary syndrome who have impaired glucose tolerance.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Coronary Heart Disease
  • Acute Coronary Syndrome
  • Impaired Glucose Tolerance
  • Type 2 Diabetes Mellitus (T2DM)
  • Drug: Acarbose
    The participants will be given one tablet (50mg) of acarbose per day to be taken with a meal during their first week (7 days). During the second week, the dose is increased to two tablets/day (50mg twice a day i.e. 100mg/day) and then three tablets/day (50mg three times a day i.e. 150mg/day) thereafter. The maximum tolerated dose will be taken for the duration of the trial (maximum dose is 150mg/day).
    Other Name: Glucobay
  • Drug: Matching Placebo
    The participants will be given one tablet of matching placebo per day to be taken with a meal during their first week (7 days). During the second week, the dose is increased to two tablets/day and then three tablets/day thereafter. The maximum tolerated dose will be taken for the duration of the trial (maximum dose is 3 tablets/day).
  • Active Comparator: Acarbose
    Intervention: Drug: Acarbose
  • Placebo Comparator: Matching Placebo
    Intervention: Drug: Matching Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
7500
October 2014
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female, aged 50 years or more.
  • Definite CHD, defined as a, b or c below:

    1. Previous myocardial infarction (MI) or Acute Coronary Syndrome (ACS), but not within the last 3 months, with any two of the following (Note: Patients with stents are eligible):

      • Typical clinical presentation
      • Confirmatory ECG changes
      • Appropriate elevation of cardiac enzymes/biomarkers
    2. Previous unstable angina (UA) or Acute Coronary Syndrome (ACS), but not within the last 3 months, with any two of the following:

      • Typical clinical presentation
      • Confirmatory ECG changes
      • Either elevation of a cardiac biomarker or a >50% stenosis in ≥1 major epicardial coronary artery shown on coronary angiography or CT angiography. Where stenosis is reported in a qualitative manner, the categories "moderate" and "severe" will be taken as equating to >50% stenosis.
    3. Current stable angina defined as:

      • Typical clinical history with symptoms occurring within the last month, and
      • A >50% stenosis in ≥1 major epicardial coronary artery shown on coronary angiography or CT angiography. Where stenosis is reported in a qualitative manner, the categories "moderate" and "severe" will be taken as equating to >50% stenosis.
  • Impaired glucose tolerance diagnosed on a single 75g anhydrous glucose OGTT, defined as a 2-hour plasma glucose (2HPG) value ≥7.8 but <11.1 mmol/l and a fasting plasma glucose (FPG) <7.0 mmol/l within six months prior to enrollment.
  • Optimised cardiovascular drug therapy.
  • At least 80% adherent to single blind placebo Study Medication during the run-in period.
  • Provision of written informed consent.

Exclusion Criteria:

  • Previous history of diabetes, other than gestational diabetes.
  • MI, unstable angina, stroke or a transient ischaemic attack (TIA) within the previous three months.
  • Planned or anticipated coronary, cerebrovascular or peripheral arterial revascularisation or other major surgical intervention.
  • NYHA class III or IV heart failure.
  • Evidence of severe hepatic disease.
  • Evidence of severe renal impairment or an eGFR <30 ml/min/1.73m2 (derived using the MDRD Chinese equation)
  • Any other condition likely to reduce adherence to the protocol e.g. alcoholism, major active psychiatric disorder, cognitive impairment or a condition likely to markedly limit life expectancy e.g. malignancy.
  • Pregnancy (or planned pregnancy within the next five years).
  • Concurrent participation in any other clinical interventional trial.
  • Known intolerance to alpha glucosidase inhibitors or gastrointestinal problems.
  • Thought by the investigator for any reason to be unsuitable for participation in this clinical study.
Both
50 Years and older
No
Contact: Professor Rury R Holman, FRCP +44 (0) 1865 857240 ace@dtu.ox.ac.uk
China
 
NCT00829660
11232, ISRCTN91899513
Yes
Professor Rury Holman, Diabetes Trials Unit, University of Oxford
University of Oxford
Bayer
Principal Investigator: Professor Rury R Holman, FRCP Diabetes Trials Unit, University of Oxford
University of Oxford
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP