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Acarbose Cardiovascular Evaluation Trial (ACE)

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT00829660
First received: January 26, 2009
Last updated: July 21, 2017
Last verified: July 2017
January 26, 2009
July 21, 2017
February 17, 2009
April 11, 2017   (Final data collection date for primary outcome measure)
A composite cardiovascular outcome defined as the time after randomisation to the first occurrence of any one of the following: -Cardiovascular death -Non-fatal MI -Non-fatal stroke -Hospitalisation for Unstable Angina -Hospitalisation for Heart Failure [ Time Frame: Follow-up until 728 adjudicated Primary Outcome Measures have been recorded ]
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 ]
Complete list of historical versions of study NCT00829660 on ClinicalTrials.gov Archive Site
  • Transition to type 2 diabetes confirmed by two successive diagnostic plasma glucose values (FPG >7.0 mmol/l and/or 2HPG > 11.1 mmol/l), with no intervening non-diagnostic values.
  • All cause mortality
  • Each of the components of the primary composite cardiovascular outcome will also be analysed individually, both as first and as total events.
  • Major Cardiovascular Event (MACE) composite cardiovascular outcome, defined as the time after randomisation to the first occurrence of any one of the following: - Cardiovascular death - Non-fatal MI - Non-fatal stroke
  • Impaired renal function as evidenced by: A reduced estimate of glomerular filtration rate( eGFR <30 ml/minute/ 1.73 m2) estimated using the Chinese MDRD formula, a doubling of the baseline plasma creatinine level, a halving of the baseline eGFR
  • Resource use, costs and cost effectiveness
  • Transition to type 2 diabetes [ Time Frame: Follow-up for approximately 4 years until 904 adjudicated Primary Outcome Measures have been recorded. ]
  • All cause mortality [ Time Frame: Follow-up for approximately 4 years until 904 adjudicated Primary Outcome Measures have been recorded. ]
  • 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. ]
  • Evidence of NAFLD [ Time Frame: Follow-up for approximately 4 years until 904 adjudicated Primary Outcome Measures have been recorded. ]
  • Impaired renal function [ Time Frame: Follow-up for approximately 4 years until 904 adjudicated Primary Outcome Measures have been recorded. ]
Not Provided
Not Provided
 
Acarbose Cardiovascular Evaluation Trial
A Long-term, Multicentre, Double-blind, Randomised Parallel-group Trial to Determine Whether Reducing Post-prandial Glycaemia Can Reduce Cardiovascular-related Morbidity and Mortality 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 long-term, multicentre, double-blind, randomised parallel-group trial to determine whether reducing post-prandial glycaemia can reduce cardiovascular-related morbidity and mortality in patients with established coronary heart disease or acute coronary syndrome who have impaired glucose tolerance.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Coronary Heart Disease
  • Acute Coronary Syndrome
  • Impaired Glucose Tolerance
  • Type 2 Diabetes Mellitus (T2DM)
  • Drug: Acarbose
    The participants were given one tablet (50mg) of acarbose per day, taken with a meal during their first week (7 days). During the second week, the dose was 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 is being taken for the duration of the trial (maximum dose is 150mg/day).
    Other Name: Glucobay
  • Drug: Matching Placebo
    The participants were given one tablet of matching placebo per day, taken with a meal during their first week (7 days). During the second week, the dose was increased to two tablets/day and then three tablets/day thereafter. The maximum tolerated dose is being taken for the duration of the trial (maximum dose is 3 tablets/day).
  • Active Comparator: Acarbose
    The participants were given one tablet (50mg) of acarbose per day, taken with a meal during their first week (7 days). During the second week, the dose was 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 is being taken for the duration of the trial (maximum dose is 150mg/day).
    Intervention: Drug: Acarbose
  • Placebo Comparator: Matching Placebo
    The participants were given one tablet of matching placebo per day, taken with a meal during their first week (7 days). During the second week, the dose was increased to two tablets/day and then three tablets/day thereafter. The maximum tolerated dose is being taken for the duration of the trial (maximum dose is 3 tablets/day).
    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.
 
Completed
6526
April 18, 2017
April 11, 2017   (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:

      • 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 standard oral glucose tolerance test (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, at the time of randomisation
  • New York Heart Association (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 Modification of Diet in Renal Disease, 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. Note: Patients who were treated previously with an alphaglucosidase inhibitor must have at least a three-month washout period before being randomised into the ACE 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.
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China,   Hong Kong
 
 
NCT00829660
11232
ISRCTN91899513
Yes
Not Provided
Plan to Share IPD: Undecided
University of Oxford
University of Oxford
Bayer
Principal Investigator: Professor Rury R Holman, FRCP FMedSci Diabetes Trials Unit, University of Oxford
University of Oxford
July 2017

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