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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | |
Unique ID issued by UMIN | UMIN000001720 |
Receipt No. | R000002008 |
Scientific Title | Evaluation of the effect of Angiotensin ll receptor blocker for plaque vulnerability after percutaneous coronary intervention (PCI) |
Date of disclosure of the study information | 2009/02/23 |
Last modified on | 2009/02/12 |
Basic information | ||
Public title | Evaluation of the effect of Angiotensin ll receptor blocker for plaque vulnerability after percutaneous coronary intervention (PCI) | |
Acronym | Telmisartan for plaque regression | |
Scientific Title | Evaluation of the effect of Angiotensin ll receptor blocker for plaque vulnerability after percutaneous coronary intervention (PCI) | |
Scientific Title:Acronym | Telmisartan for plaque regression | |
Region |
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Condition | ||
Condition | Hypertension with coronary artery disease | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Comparison of effect of Telmisartan and non-RAS blocker on Plaque vulnerability |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Phase IV |
Assessment | |
Primary outcomes | Change in plaque composition and observation by Integrated Backscatter Intravascular Ultrasound (IB-IVUS) |
Key secondary outcomes | 1) Change in surrogate marker in coronary vein blood
hs-CRP,IL-6,TNF-alpha,IP-10,MMP-3, MMP-9,MCP-1,MIF,PTX-3,Heparin cofactor 2) Office blood pressure |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Telmisartan + Pravastatin sodium | |
Interventions/Control_2 | Antiypertensive agents except RAS blocker + Pravastatin sodium | |
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | 1) Patients after bere-metal stent implantation, confirmed>=75% stenosis in 1-2 branch by angiography
2) Lesions diameter>=3mm 3) Patients with metabolic syndrome 4) Patients with hypertension 5) LDL cholesterol level>=100mg/dl |
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Key exclusion criteria | 1) Previous storoke<=6month
2) Ejection fraction<=40% 3) Patients with dialysis 4) Diabetic patients with HbA1c<=6.5 5) Patients who are treated with statin except pravastatin sodium |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | The University of Tokushima | ||||||
Division name | Cardiovascular Medicine | ||||||
Zip code | |||||||
Address | 3-18-15 Kuramoto-Cho Tokushima | ||||||
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Organization | The University of Tokushima Institute of Health Biosciences Graduate School | ||||||
Division name | Cardiovascular Medicine | ||||||
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TEL | 088-633-7852 | ||||||
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Sponsor | |
Institute | The University of Tokushima, Cardiovascular Medicine |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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IPD sharing Plan description |
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Management information | |||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002008 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |