Glucose Metabolism DisordersPhase 3NCT00221156
Acarbose and Secondary Prevention After Coronary Stenting
A Phase 3 study testing Acarbose in people with Glucose Metabolism Disorders and Coronary Artery Disease, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 3 sites in Japan.
Trial summary
The purpose of this study is to determine whether the intervention for newly diagnosed abnormal glucose tolerance after coronary stenting will improve the long-term clinical outcome. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Glucose Metabolism Disorders, Coronary Artery Disease
- What is being tested?
- Acarbose
- How many people
- 300 participants
- Where
- 3 sitesJapan
- Study dates
- May 2005to Apr 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Within 8 weeks since implantation of coronary artery stents for stable angina pectoris or acute coronary syndrome.
- Abnormal glucose tolerance according to a 75 g oral glucose tolerance test (OGTT).
- HbA1c is less than 6.5%.
- Age is between 20 and 75 years (at time of consent).
- Patients who can give informed consent themselves in writing.
Who cannot join
- Patients with abnormal glucose tolerance caused by other organic disorders such as pancreatitis, hemochromatosis, post pancreatectomy, hyperthyroidism, Cushing syndrome, Prader-Willi syndrome, etc.
- Patients with planned angioplasty.
- Patients with uncontrollable congestive heart failure.
- Less than 6 months since last episode of cerebral infarction.
- Patients who have received medication for diabetes mellitus before.
- AST (GOT) exceeding 100 IU/L or ALT (GPT) exceeding 100 IU/L.
Show all 13Show fewer
- Creatinine exceeding 2 mg/dl.
- Patients with a history of ileus or less than 6 months since celiotomy.
- Pregnant women or those who plan to become pregnant, or are in the lactation period.
- Habitual drinker (more than 100 ml/day of alcohol).
- Patients with a history of gastrectomy.
- Patients for whom it is impossible to follow up for 5 years.
- Any other reason that the clinical supervisors or clinical researchers may have for considering a case unsuitable for the study.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Institute of Biomedical Research and Innovation.
Kobe, Hyogo Pref., 650-0047
Kobe City General Hospital/Institute of Biomedical Research and Innovation
Kobe, Hyogo Pref., 650-0047
Kawasaki Medical School Hospital
Kurashiki, Okayama-ken, 701-0192
About this study
Official title: Effects of Acarbose Long-Term Therapy on Prevention of Cardiovascular Events in Abnormal Glucose Tolerance With Coronary Artery Disease (ALERT Study)
The purpose of this study is to determine whether the intervention for newly diagnosed abnormal glucose tolerance after coronary stenting will improve the long-term clinical outcome.
Read the detailed description
Recent studies have demonstrated that newly diagnosed abnormal glucose tolerance (AGT; diabetes mellitus and impaired glucose tolerance) are common among the patients with ischemic heart disease. Several large cohort studies indicate that people with prediabetic conditions, such as impaired glucose tolerance, have a raised risk of future cardiovascular disease. Intervention with acarbose can prevent myocardial infarction and cardiovascular disease in type 2 diabetic and IGT patients. However, the effect of acarbose to secondary prevention of myocardial infarction or cardiovascular events in patients with newly diagnosed AGT after coronary stenting remains unclear. The purpose of the present study is to determine whether the intervention to such abnormalities after coronary stenting will improve the long-term clinical outcome. This is a opened, randomized study to compare acarbose versus a standard lifestyle modification. Patients will have a 1:1 chance of receiving acarbose versus the standard lifestyle modification. There is some research evidence that suggests acarbose may improve clinical outcome in patients with type 2 diabetes and in IGT patients.
- Being tested
- Acarbose
- Keywords
- Abnormal Glucose Tolerance, coronary artery disease, diabetes mellitus, clinical outcome
- Medical subject headings
- Glucose Metabolism Disorders, Coronary Artery Disease, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcarboseDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular event free survival time
Secondary outcomes (8)
Conversion of abnormal glucose tolerance to type 2 diabetes
All causes of death
Occurrence of every cardiovascular event
Occurrence of in-stent restenosis
Change in fasting, 2-hour blood glucose and insulin level
Change in homeostasis model assessment of insulin resistance
Change in hemoglobin A1c (HbA1c)
Change in lipid profile
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMay 2005
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucose Metabolism DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan, Kobe City General Hospital
- Investigators
- Koichi Tamita, MD., Principal investigator, Division of Cardiology, Kobe General HospitalMinako Katayama, MD, Study director, Division of Clinical Research Promotion, Institute of Biomedical Research and Innovation.Yutaka Furukawa, MD, Study director, Division of Cardiology, Kobe General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221156
- Sponsor's protocol ID
- BRI_CAD_04-02
- Status last verified
- Jun 2009
- First submitted
- 13 Sep 2005
- Last updated
- 25 Jun 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acarbose Long-Term Therapy on Prevention of Cardiovascular Events in Abnormal Glucose Tolerance With Coronary Artery Disease (ALERT Study)
- ClinicalTrials.gov ID
- NCT00221156
- Acronym / sponsor ID
- BRI_CAD_04-02
- Keywords
- Abnormal Glucose Tolerance, coronary artery disease, diabetes mellitus, clinical outcome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Translational Research Center for Medical Innovation, Kobe, Hyogo, JapanUniversity, hospital or other
- Collaborators
- Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan, Kobe City General Hospital
- Study start
- May 2005
- Study completion
- Apr 2009 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the intervention for newly diagnosed abnormal glucose tolerance after coronary stenting will improve the long-term clinical outcome.
Detailed description
Recent studies have demonstrated that newly diagnosed abnormal glucose tolerance (AGT; diabetes mellitus and impaired glucose tolerance) are common among the patients with ischemic heart disease. Several large cohort studies indicate that people with prediabetic conditions, such as impaired glucose tolerance, have a raised risk of future cardiovascular disease. Intervention with acarbose can prevent myocardial infarction and cardiovascular disease in type 2 diabetic and IGT patients. However, the effect of acarbose to secondary prevention of myocardial infarction or cardiovascular events in patients with newly diagnosed AGT after coronary stenting remains unclear. The purpose of the present study is to determine whether the intervention to such abnormalities after coronary stenting will improve the long-term clinical outcome. This is a opened, randomized study to compare acarbose versus a standard lifestyle modification. Patients will have a 1:1 chance of receiving acarbose versus the standard lifestyle modification. There is some research evidence that suggests acarbose may improve clinical outcome in patients with type 2 diabetes and in IGT patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Within 8 weeks since implantation of coronary artery stents for stable angina pectoris or acute coronary syndrome.
- Abnormal glucose tolerance according to a 75 g oral glucose tolerance test (OGTT).
- HbA1c is less than 6.5%.
- Age is between 20 and 75 years (at time of consent).
- Patients who can give informed consent themselves in writing.
Key exclusion criteria (13 listed)
- Patients with abnormal glucose tolerance caused by other organic disorders such as pancreatitis, hemochromatosis, post pancreatectomy, hyperthyroidism, Cushing syndrome, Prader-Willi syndrome, etc.
- Patients with planned angioplasty.
- Patients with uncontrollable congestive heart failure.
- Less than 6 months since last episode of cerebral infarction.
- Patients who have received medication for diabetes mellitus before.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acarbose | Drug | – |
Primary outcome
Cardiovascular event free survival time
8 secondary outcomes
Conversion of abnormal glucose tolerance to type 2 diabetes
All causes of death
Occurrence of every cardiovascular event
Occurrence of in-stent restenosis
Change in fasting, 2-hour blood glucose and insulin level
Change in homeostasis model assessment of insulin resistance
Change in hemoglobin A1c (HbA1c)
Change in lipid profile
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koichi Tamita, MD. principal investigator
Division of Cardiology, Kobe General Hospital
Minako Katayama, MD study director
Division of Clinical Research Promotion, Institute of Biomedical Research and Innovation.
Yutaka Furukawa, MD study director
Division of Cardiology, Kobe General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acarbose in people with Glucose Metabolism Disorders and Coronary Artery Disease, run by Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular event free survival time. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2009.