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Oxidative StressPhase 2NCT00771004

Efficacy of Pioglitazone on Myocardial Function in Patients Undergoing Coronary Stent Implantation.

A Phase 2 study testing Pioglitazone in people with Oxidative Stress and Coronary Artery Disease, run by Takeda at 7 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine the effects of pioglitazone, once daily (QD), on heart functioning before, during and after stent implantation. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Pioglitazone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
63 participants
Where
7 sitesGermany
Study dates
Aug 2006to Feb 2009
Phase
Phase 2
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Stable coronary artery disease with planned percutaneous coronary intervention with stent implantation.
  • Type II-diabetics and/or an IRIS II score greater than or equal to 50 (measure for the identification of patients with insulin resistance and increased vascular risk).
  • Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

Who cannot join

  • A planned percutaneous coronary intervention with stent implantation less than 15 days after the screening visit.
  • Planned multi-vessel intervention.
  • Use of systemic corticosteroids within the last 3 months prior to screening visit.
  • Anamnestic history of hypersensitivity to the study drugs or to drugs with similar chemical structures.
  • History of severe or multiple allergies.
  • Treatment with any other investigational drug within 3 months before trial entry or earlier participation in the present study.
Show all 15Show fewer
  • Have had more than one unexplained episode of severe hypoglycemia (defined as requiring assistance of another person due to disabling hypoglycemia) within 6 months prior to screening visit.
  • Progressive fatal disease.
  • History of drug or alcohol abuse within the last 10 years.
  • A history of significant cardiovascular (New York Health Association stage II - IV), respiratory, gastrointestinal, hepatic (alanine aminotransferase greater than 2.5 times the normal reference range), renal (creatinine greater than 1.2 mg/dL in women and greater than 1.5 in men and/or glomerular filtration rate less than 45), neurological, psychiatric and/or hematological disease as judged by the Investigator.
  • Pre-treatment with peroxisome proliferator-activated receptor (gamma) agonists within the 3 months prior to screening.
  • If insulin therapy applicable: initiation of insulin therapy within the last 3 months.
  • If statin therapy applicable: change of medication within the last 4 weeks.
  • Myocardial infarction within 3 months prior to screening visit.
  • Blood donation within last 30 days.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Germany7 sites

  • Study site

    Frankfurt am Main, Hesse

  • Study site

    Hamburg, Free and Hanseatic City of Hamburg

  • Study site

    Jena, Thuringia

  • Study site

    Kassel, Hesse

  • Study site

    Mainz, Rhineland-Palatinate

  • Study site

    Wiesbaden, Hesse

  • Study site

    Wuppertal, North Rhine-Westphalia

Other trials in Germany

About this study

Official title: Pilot Trial Studying the Effects of Pioglitazone in Comparison to Placebo on Myocardial Function and Oxidative Stress in Patients With Type II Diabetes and Insulin Resistance Undergoing Elective PTCA. A Randomized Double-blinded Phase II Study.

The purpose of this study is to determine the effects of pioglitazone, once daily (QD), on heart functioning before, during and after stent implantation.

Read the detailed description

Type 2 diabetes increases the risk of coronary heart disease at least by two to three fold compared with non-diabetic subjects. Moreover, prospective studies have shown a significant correlation between several glycemic confounders and morbidity from coronary heart disease even in patients without diabetes mellitus. In patients with previously diagnosed coronary heart disease, impaired glucose tolerance was found in 30 to 67 %. The cardiovascular risk of patients with insulin resistance, with or without glucose intolerance has become more and more apparent within recent years and quantitative coronary angiographic studies have revealed a correlation between the severity of coronary heart disease and impaired glucose tolerance.

A new pharmaceutical class for the intervention of insulin resistance, the peroxisome proliferator activated receptor (gamma) agonists have been successfully introduced in the treatment of type 2 diabetes. Beyond their metabolic effects on glucose and lipid metabolism, peroxisome proliferator activated receptor (gamma) agonists show to exert a couple of pleiotropic, anti-inflammatory and vasoprotective effects in patients with type 2 diabetes and impaired glucose tolerance.

The incidence and severity of peri-procedural myocardial injury during percutaneous coronary interventions with stent implantation in diabetic and in non-diabetic patients is an important prognostic confounder for the patient. Different laboratory biomarkers have been investigated as diagnostic tools for the estimation of the risk of peri-procedural myocardial injury. Recent studies have convincingly demonstrated that the risk of subsequent ischemic heart events is related to the extent of cardiac troponin or CK-MB increase after coronary intervention, and the prognosis for these individuals is usually worse than that for patients who do not develop an increase in these biomarkers.

In a recent trial it was shown that pretreatment with atorvastatin could reduce procedural myocardial injury in elective coronary intervention. The incidence of Troponin I increase was 48% in the placebo group compared to 20% in the atorvastatin group.

The aim of this study is to investigate the effect of pioglitazone on the incidence of peri-procedural myocardial injury in patients undergoing percutaneous coronary interventions with stent implantation. Total participation time is anticipated to be 3 weeks.

Being tested
Pioglitazone, Placebo
Keywords
drug effects, Type II Diabetes, Angioplasty, Transluminal, Percutaneous Coronary, Drug Therapy, Heart, physiology, function
Medical subject headings
Coronary Artery Disease, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PioglitazoneDrug

    Also called ACTOS®, AD4833

    Pioglitazone 30 mg, tablets, orally, once daily for one week; increased to Pioglitazone 45 mg, tablets, orally, once daily for up to two weeks.

  • PlaceboDrug

    Pioglitazone placebo-matching tablets, orally, once daily for up to three weeks.

Study groups in NCT00771004
Study groupRoleWhat they receive
Pioglitazone 30 mg to 45 mg QDExperimentalNot described
Receives: Drug: Pioglitazone
Placebo QDPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Cardiac Troponin I elevation (greater than 1 upper limit of normal) post-percutaneous coronary intervention with stent implantation.

    Measured: 24 hours post stent implantation.

Secondary outcomes (12)

  1. Incidence of Creatine Kinase (Myocard-type) post-percutaneous coronary intervention with stent implantation.

    Measured: 24 hours post stent implantation.

  2. Mean peak values of Troponin I and Creatine Kinase (Myocard-type) post-percutaneous coronary intervention with stent implantation.

    Measured: Hours: 2, 6 and 12 and 24 post stent implantation.

  3. Frequency of Doppler-detected microembolism measured by high intensity transient signals during percutaneous coronary intervention with stent implantation (sub-study Jena only).

    Measured: Duration of stent implantation surgery.

  4. Time course of Troponin I Laboratory Procedure.

    Measured: Visits: 2, 3, 4, 5, 6, 7, and 8 or Final Visit.

  5. Time course of high-sensitive-C-Reactive Peptide Laboratory Procedure.

    Measured: Visits: 2, 3, 4, 5, 6, 7, and 8 or Final Visit.

  6. Time course of nitrotyrosine Laboratory Procedure.

    Measured: Visits: 2, 3, 4, 5, 6, 7, and 8 or Final Visit.

  7. Time course of Asymmetric dimethylarginine Laboratory Procedure.

    Measured: Visits: 2, 3, 4, 5, 6, 7, and 8 or Final Visit.

  8. Time course of E-selectin Laboratory Procedure.

    Measured: Visits: 2, 3, 4, 5, 6, 7, and 8 or Final Visit.

  9. Time course of Myoglobin Laboratory Procedure.

    Measured: Visits: 2, 3, 4, 5, 6, 7, and 8 or Final Visit.

  10. Time course of Visfatin Laboratory Procedure.

    Measured: Visits: 2, 3, 4, 5, 6, 7, and 8 or Final Visit.

  11. Time course of Proinsulin intact Laboratory Procedure.

    Measured: Visits: 1 and 7 or Final Visit.

  12. Time course of Adiponectin Laboratory Procedure.

    Measured: Visits: 1 and 7 or Final Visit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2008 (estimated)
  2. Study startAug 2006
  3. Primary completionFeb 2009
  4. Study completionFeb 2009

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00771004
Sponsor's protocol ID
ATS K021
Other IDs
2006-002237-20, D-PIO-111, U1111-1115-9160
Status last verified
Jul 2010
First submitted
9 Oct 2008
Last updated
5 Jul 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pioglitazone in people with Oxidative Stress and Coronary Artery Disease, run by Takeda at 7 sites in Germany.

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 3 inclusion and 15 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 5 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Germany. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Incidence of Cardiac Troponin I elevation (greater than 1 upper limit of normal) post-percutaneous coronary intervention with stent implantation. (time frame: 24 hours post stent implantation.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00771004.

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 5 Jul 2010.

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