Acarbose Cardiovascular Evaluation Trial - Full Text View

Sponsor:	University of Oxford
Collaborator:	Bayer
Information provided by:	University of Oxford
ClinicalTrials.gov Identifier:	NCT00829660

Purpose

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.

Condition	Intervention	Phase
Coronary Heart Disease Acute Coronary Syndrome Impaired Glucose Tolerance Type 2 Diabetes Mellitus (T2DM)	Drug: Acarbose Drug: Matching Placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	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.

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Coronary Artery Disease Diabetes Diabetes Type 2 Heart Diseases

Drug Information available for: Acarbose

U.S. FDA Resources

Further study details as provided by University of Oxford:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	7500
Study Start Date:	February 2009
Estimated Study Completion Date:	October 2014
Estimated Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Acarbose	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
Placebo Comparator: Matching Placebo	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).

Arms

Assigned Interventions

Active Comparator: Acarbose

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

Placebo Comparator: Matching Placebo

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).

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829660

Contacts

Contact: Professor Rury R Holman, FRCP

+44 (0) 1865 857240

ace@dtu.ox.ac.uk

Show 150 Study Locations

Sponsors and Collaborators

University of Oxford

Bayer

Investigators

Principal Investigator:

Professor Rury R Holman, FRCP

Diabetes Trials Unit, University of Oxford

More Information

Additional Information:

Diabetes Trials Unit, International Co-ordinating Centre for the ACE Trial This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Professor Rury Holman, Diabetes Trials Unit, University of Oxford
ClinicalTrials.gov Identifier:	NCT00829660 History of Changes
Other Study ID Numbers:	11232, ISRCTN91899513
Study First Received:	January 26, 2009
Last Updated:	September 27, 2011
Health Authority:	China: State Food and Drug Administration

Keywords provided by University of Oxford:

Acarbose

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Heart Diseases
Glucose Intolerance
Acute Coronary Syndrome
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Glucose Metabolism Disorders

Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Acarbose
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012