--- a +++ b/matching/trials/NCT01162902.xml @@ -0,0 +1,196 @@ +<?xml version="1.0" encoding="UTF-8"?> +<clinical_study rank="112636"> + <!-- This xml conforms to an XML Schema at: + https://clinicaltrials.gov/ct2/html/images/info/public.xsd + and an XML DTD at: + https://clinicaltrials.gov/ct2/html/images/info/public.dtd --> + <required_header> + <download_date>ClinicalTrials.gov processed this data on December 16, 2015</download_date> + <link_text>Link to the current ClinicalTrials.gov record.</link_text> + <url>https://clinicaltrials.gov/show/NCT01162902</url> + </required_header> + <id_info> + <org_study_id>ABC Trial</org_study_id> + <nct_id>NCT01162902</nct_id> + </id_info> + <brief_title>Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation</brief_title> + <official_title>Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation</official_title> + <sponsors> + <lead_sponsor> + <agency>Seoul National University Hospital</agency> + <agency_class>Other</agency_class> + </lead_sponsor> + </sponsors> + <source>Seoul National University Hospital</source> + <oversight_info> + <authority>South Korea: Korea Food and Drug Administration (KFDA)</authority> + <has_dmc>Yes</has_dmc> + </oversight_info> + <brief_summary> + <textblock> + Treatments for stable angina includes drug therapy such as calcium-channel blocker, beta + blocker, and ACEI/ARB. To obtain good prognosis in patients with coronary artery + disease,preventing or correcting the progression of atherosclerosis and dyslipidemia is more + important than relieving angina symptom. Dysfunction of microvessel is one of the most + important factor in patients with coronary artery disease. Recently, we developed the new + non-invasive method of evaluating the microvessel in fundus. With this methods, we will + compare the effect of each drug (beta blocker, CCB, ARB). + </textblock> + </brief_summary> + <overall_status>Not yet recruiting</overall_status> + <start_date>September 2013</start_date> + <completion_date type="Anticipated">December 2015</completion_date> + <primary_completion_date type="Anticipated">January 2015</primary_completion_date> + <phase>Phase 4</phase> + <study_type>Interventional</study_type> + <study_design>Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment</study_design> + <primary_outcome> + <measure>Wall to lumen ratio of fundus vessel</measure> + <time_frame>baseline, 9 months</time_frame> + <safety_issue>No</safety_issue> + <description>Measurement of change in the ratio of wall thickness to lumen of the fundus vessel from baseline to 9 month follow up</description> + </primary_outcome> + <secondary_outcome> + <measure>lipid parameter</measure> + <time_frame>baseline, 9 months</time_frame> + <safety_issue>No</safety_issue> + <description>Measurement of change in total cholesterol, triglyceride, LDL, small dense LDL, and HDL</description> + </secondary_outcome> + <secondary_outcome> + <measure>Serum markers of inflammation</measure> + <time_frame>baseline, 9 months</time_frame> + <safety_issue>No</safety_issue> + <description>CRP</description> + </secondary_outcome> + <secondary_outcome> + <measure>Change of nitrate need</measure> + <time_frame>baseline, 1 months, and 3 months</time_frame> + <safety_issue>No</safety_issue> + <description>Measure of change of nitrate need</description> + </secondary_outcome> + <number_of_arms>3</number_of_arms> + <enrollment type="Anticipated">150</enrollment> + <condition>Stable Angina</condition> + <arm_group> + <arm_group_label>Diltiazem treated group</arm_group_label> + <arm_group_type>Experimental</arm_group_type> + <description>Diltiazem 180mg treated group</description> + </arm_group> + <arm_group> + <arm_group_label>Bisoprolol treated group</arm_group_label> + <arm_group_type>Active Comparator</arm_group_type> + <description>Bisoprolol 5mg treated group</description> + </arm_group> + <arm_group> + <arm_group_label>Candesartan treated group</arm_group_label> + <arm_group_type>Active Comparator</arm_group_type> + <description>Candesartan 32mg treated group</description> + </arm_group> + <intervention> + <intervention_type>Drug</intervention_type> + <intervention_name>Diltiazem treated group</intervention_name> + <description>Diltiazem 180mg for 9 months</description> + <arm_group_label>Diltiazem treated group</arm_group_label> + </intervention> + <intervention> + <intervention_type>Drug</intervention_type> + <intervention_name>Bisoprolol treated group</intervention_name> + <description>Bisoprolol 5mg for 9 months</description> + <arm_group_label>Bisoprolol treated group</arm_group_label> + </intervention> + <intervention> + <intervention_type>Drug</intervention_type> + <intervention_name>Candesartan treated group</intervention_name> + <description>Candesartan 32mg for 9 months</description> + <arm_group_label>Candesartan treated group</arm_group_label> + </intervention> + <eligibility> + <criteria> + <textblock> + Inclusion Criteria: + + - Stable angina patients whose coronary lesions is confirmed by angiography or receives + PCI + + - Unstable Angina/NSTEMI patients who completed PCI for main lesions + + - Either systolic > 130mmHg or diastolic > 80mmHg, or patients with anti-hypertensive + drugs + + Exclusion Criteria: + + - STEMI patients within one month + + - Variant Angina + + - Liver function abnormality or renal failure + + - History of Hypersensitivity to testing drugs + + - Severe heart failure(NYHA class>3) or uncorrectable hematologic disease + + - Woman possible to be pregnant + + - Uncontrolled diabetes + + - Expected life span < one year + </textblock> + </criteria> + <gender>Both</gender> + <minimum_age>30 Years</minimum_age> + <maximum_age>80 Years</maximum_age> + <healthy_volunteers>No</healthy_volunteers> + </eligibility> + <overall_contact> + <last_name>Hae-Young Lee, MD, PhD</last_name> + <phone>82-10-4528-6160</phone> + <email>hylee612@snu.ac.kr</email> + </overall_contact> + <overall_contact_backup> + <last_name>Hyo-Soo Kim, MD, PhD</last_name> + <phone>82-2-2072-2226</phone> + <email>hyosoo@snu.ac.kr</email> + </overall_contact_backup> + <location> + <facility> + <name>Seoul National University Hospital</name> + <address> + <city>Seoul</city> + <country>Korea, Republic of</country> + </address> + </facility> + <status>Not yet recruiting</status> + <investigator> + <last_name>Hyo-Soo Kim, MD, PhD</last_name> + <role>Principal Investigator</role> + </investigator> + <investigator> + <last_name>Hae-Young Lee, MD,PhD</last_name> + <role>Sub-Investigator</role> + </investigator> + </location> + <location_countries> + <country>Korea, Republic of</country> + </location_countries> + <verification_date>December 2013</verification_date> + <lastchanged_date>December 15, 2013</lastchanged_date> + <firstreceived_date>April 30, 2010</firstreceived_date> + <responsible_party> + <name_title>Hyo-Soo, Kim</name_title> + <organization>Seoul National University Hospital</organization> + </responsible_party> + <is_fda_regulated>No</is_fda_regulated> + <has_expanded_access>No</has_expanded_access> + <condition_browse> + <!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm --> + <mesh_term>Angina, Stable</mesh_term> + </condition_browse> + <intervention_browse> + <!-- CAUTION: The following MeSH terms are assigned with an imperfect algorithm --> + <mesh_term>Bisoprolol</mesh_term> + <mesh_term>Candesartan</mesh_term> + <mesh_term>Candesartan cilexetil</mesh_term> + <mesh_term>Diltiazem</mesh_term> + </intervention_browse> + <!-- Results have not yet been posted for this study --> +</clinical_study>