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Stent
Stents + Rosiglitazone for Coronary Artery Disease in Diabetics
Phase 2 & 3
Waitlist Available
Led By Herman K Gold, MD
Research Sponsored by Gold, Herman K., MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must be previously diagnosed with type 2 diabetes with documented treatment with insulin, oral hypoglycemics, or diet controlled by medical history
Diagnosis of angina pectoris defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II-III) OR patients with documented silent ischemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial will test whether a combination of two different types of stents and an oral diabetes drug will reduce restenosis (reexcessive growth of tissue) after stenting in type 2 diabetic patients.
Who is the study for?
This trial is for adults over 18 with type 2 diabetes and coronary artery disease, who experience angina or silent ischemia, have specific lesion sizes in their arteries, and are on diabetes treatment. Excluded are those with severe liver, heart or kidney issues, certain medication use, recent major heart attacks, life expectancy under a year or potential childbearing without contraception.Check my eligibility
What is being tested?
The study tests if using the VISION stent along with rosiglitazone (an oral drug) can reduce artery re-narrowing after stenting in diabetic patients. It's an alternative to drug-eluting stents aiming for cost-effectiveness and efficiency.See study design
What are the potential side effects?
Possible side effects include typical risks associated with taking rosiglitazone such as fluid retention leading to swelling and weight gain; increased risk of bone fractures; and changes in blood lipid levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have type 2 diabetes and have been treated with insulin, pills, or diet.
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I have been diagnosed with chest pain or silent heart issues.
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I need stents for two separate blockages in my heart's arteries.
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My heart blockage is less than 25 mm in my own artery.
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My heart disease involves new blockages in my heart's original arteries.
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I am older than 18 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
In-stent and In-segment late lumen loss
Secondary outcome measures
(There are 3 more secondary endpoints not listed here.)
Composite of Major Adverse Cardiac Events (MACE)
Coronary artery stenosis progression in at least one non-stented lesion
+7 moreFind a Location
Who is running the clinical trial?
Gold, Herman K., MDLead Sponsor
1 Previous Clinical Trials
1 Trials studying Coronary Artery Disease
Guidant CorporationIndustry Sponsor
35 Previous Clinical Trials
13,553 Total Patients Enrolled
1 Trials studying Coronary Artery Disease
988 Patients Enrolled for Coronary Artery Disease
Herman K Gold, MDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
1 Trials studying Coronary Artery Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have type 2 diabetes and have been treated with insulin, pills, or diet.I had a severe heart attack in the last 24 hours.I have had brachytherapy on the targeted blood vessel.My liver is not functioning properly (ALT levels are high).My kidney function is impaired with high creatinine levels.My heart condition involves a blockage in a major artery branch that needs stenting.I have severe blockages in three major heart arteries needing treatment.I have been diagnosed with chest pain or silent heart issues.I need stents for two separate blockages in my heart's arteries.My heart blockage is less than 25 mm in my own artery.My heart disease involves new blockages in my heart's original arteries.I cannot take certain heart attack or stroke prevention medications.I am currently taking a TZD medication like Avandia or Actos.I have a long-term or recurring condition that causes my body to destroy red blood cells.I have a significant blockage in the main artery of my heart.I've been hospitalized for diabetic ketoacidosis more than twice in the last 6 months.My target lesion is in a vein graft or chest artery graft.My target lesion is caused by restenosis.I have received a heart transplant.My heart's pumping ability is significantly reduced.I am older than 18 years.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people currently enrolling in this clinical trial?
"Unfortunately, this particular clinical trial is not actively recruiting patients right now. According to the information found on clinicaltrials.gov, the last time this study was updated was on May 15th, 2007. Although, it is worth mentioning that there are 1,754 other clinical trials that are currently looking for participants."
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