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Dexamethasone-Eluting Stent in Acute Coronary Syndrome to Prevent Restenosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00190099
First Posted: September 19, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Far Eastern Memorial Hospital
  Purpose

The major obstacle of the long- termed success of percutaneous coronary intervention (PCI) is the restenosis. Restenosis results from complex pathophysiological response of the vascular tissue to the balloon injury. In the pre-stent era, 80% of it was attributed to vascular recoil. However, by way of the mechanical support of metallic stent, recoil is no more the major reason of restenosis. About 80 % of In-stent restenosis resulted from intimal hyperplasia.

The mechanism of the Intra-stent restenosis included 4 stages. First stage comprised the first 3 days after balloon injury, when the inflammatory reaction is most severe throughout the course. At that time, anti-inflammatory drug as steroid wuold be helpful to prevent the course of restenosis. Until the end of the third week, smooth muscle cells migrate and then proliferate in the second and the third stage, and the key effort to prevent restenosis right now is inhibition of cell cycle. Intravascular radiotherapy (so called Brachytherapy) and stent-based drug elution target upon them. Among them, rapamycin and paclitaxel proved to be effective both in animal and human experience. The last stage is re-epithelization, estrogen could promote the process and was considered to be effective in this stage.

Stent-based elution of corticosteroid, despite of its feasibility and safety, was not as effective as other anti-proliferation agent ( eg. Rapamycin etc). The major reason might be the patient group with coronary artery disease is a heterogenous one.

We believe if we applied corticosteroid over the patient with elevated inflammatory parameters, i.e. acute coronary syndrome (ACS) the effect of anti-restenosis would be obvious.

In this study, by a special-designed, phosphorylcholine-coated stent, dexamethasone could be readily absorbed and then gradually released locally even 4 weeks after deployment.

We expected a reduction of In-stent restenosis in ACS patient by the method with no or few systemic adverse effect of steroid; and angiographic follow-up as well as intra-vascular ultrasound assessment would be performed according to pur protocol.


Condition Intervention Phase
Vessel Restenosis Device: Dexamethasone-Eluting Stent Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

Estimated Enrollment: 40
Study Start Date: January 2003
Estimated Study Completion Date: December 2003
Detailed Description:

The major obstacle of the long- termed success of percutaneous coronary intervention (PCI) is the restenosis. Restenosis results from complex pathopysiological response of the vascular tissue to the balloon injury. In the pre-stent era, 80% of it was attributed to vascular recoil. However, by way of the mechanical support of metallic stent, recoil is no more the major reason of restenosis. About 80 % of In-stent restenosis resulted from intimal hyperplasia.

The mechanism of the Intra-stent restenosis included 4 stages. First stage comprised the first 3 days after balloon injury, when the inflammatory reaction is most severe throughout the course. At that time, anti-inflammatory drug as steroid would be helpful to prevent the course of restenosis. Until the end of the third week, smooth muscle cells migrate and then proliferate in the second and the third stage, and the key effort to prevent restenosis right now is inhibition of cell cycle. Intravascular radiotherapy (so called Brachytherapy) and stent-based drug elution target upon them. Among them, rapamycin and paclitaxel proved to be effective both in animal and human experience. The last stage is re-epithelization, estrogen could promote the process and was considered to be effective in this stage.

Stent-based elution of corticosteroid, despite of its feasibility and safety, was not as effective as other anti-proliferation agent ( eg. Rapamycin etc). The major reason might be the patient group with coronary artery disease is a heterogenous one.

We believe if we applied corticosteroid over the patient with elevated inflammatory parameters, i.e. acute coronary syndrome (ACS) the effect of anti-restenosis would be obvious.

In this study, by a special-designed, phosphorylcholine-coated stent, dexamethasone could be readily absorbed and then gradually released locally even 4 weeks after deployment.

We expected a reduction of In-stent restenosis in ACS patient by the method with no or few systemic adverse effect of steroid; and angiographic follow-up as well as intra-vascular ultrasound assessment would be performed according to pur protocol.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ACS patient

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00190099


Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
Principal Investigator: A H Li, MD Far Eastern Memorial Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00190099     History of Changes
Other Study ID Numbers: FEMH-93005
First Submitted: September 11, 2005
First Posted: September 19, 2005
Last Update Posted: December 9, 2005
Last Verified: December 2004

Keywords provided by Far Eastern Memorial Hospital:
In-stent restenosis,
Drug eluting stent,
dexamethasone,
Acute coronary syndrome

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action