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Acarbose Cardiovascular Evalu...

Acarbose Cardiovascular Evaluation Trial

Last Updated: 2017-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

6526 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-17

Study Completion Date

2017-04-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Heart Disease Acute Coronary Syndrome Impaired Glucose Tolerance Type 2 Diabetes Mellitus (T2DM)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Acarbose

Intervention Type 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).

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type DRUG

Interventions

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Acarbose

Intervention Type DRUG

Matching Placebo

Intervention Type DRUG

Other Intervention Names

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Glucobay

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Professor Rury R Holman, FRCP FMedSci

Role: PRINCIPAL_INVESTIGATOR

Diabetes Trials Unit, University of Oxford

Locations

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