<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01674686</url>
  </required_header>
  <id_info>
    <org_study_id>2011-12-069</org_study_id>
    <nct_id>NCT01674686</nct_id>
  </id_info>
  <brief_title>The Effect of Sarpogrelate and High Dose Statin on the Reduction of Coronary Spasm</brief_title>
  <official_title>A Prospective, Single-center, Randomized Study to Evaluate the Effect of Sarpogrelate, a Selective Serotonin Receptor Antagonist, and High Dose Statin on the Reduction of Coronary Spasm in the Patients With Variant Angina</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study was to to evaluate the effect of sarpogrelate, a selective serotonin&#xD;
      receptor antagonist, and high dose statin on the reduction of coronary spasm in the patients&#xD;
      with variant angina.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2012</start_date>
  <completion_date type="Anticipated">December 31, 2018</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Ergonovine provocation test 12months later</measure>
    <time_frame>1 year later</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein lever 12months later</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Variant Angina</condition>
  <arm_group>
    <arm_group_label>A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sarpogrelate versus placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Atorvastatin 80mg versus no statin or simvastatin 20 mg if LDL &gt; 130 mg/dl</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sarpogrelate</intervention_name>
    <description>Sarpogrelate 100mg twice a day</description>
    <arm_group_label>A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atorvastatin</intervention_name>
    <description>Atorvastatin 80mg daily</description>
    <arm_group_label>B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical history of chest pain compatible with variant angina; morning chest pain&#xD;
             aggravated by cold exposure.&#xD;
&#xD;
          -  Angiographically proven coronary spasm; TIMI flow &lt; 3 by spontaneous coronary spasm or&#xD;
             intracoronary ergonovine spasm provocation test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiac arrest by coronary spasm&#xD;
&#xD;
          -  Left main coronary spasm&#xD;
&#xD;
          -  Significant fixed coronary artery stenosis; Diameter stenosis &gt; 70% in the major&#xD;
             epicardial artery by coronary angiography&#xD;
&#xD;
          -  Left ventricular ejection fraction &lt; 30%&#xD;
&#xD;
          -  Coagulation disorders or bleeding tendency (Platelet count &lt; 50k, PT INR &gt; 2.0)&#xD;
&#xD;
          -  Significant liver disease (AST or ALT &gt; 100 U/ml)&#xD;
&#xD;
          -  Renal failure (S-Cr &gt; 2.0 mg/dl)&#xD;
&#xD;
          -  hypersensitivity for statin&#xD;
&#xD;
          -  Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hyeon-Cheol Gwon, MD,PhD</last_name>
    <phone>82-2-3410-3419</phone>
    <email>hcgwon@skku.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jeong Hoon Yang, MD</last_name>
    <phone>82-2-3410-3419</phone>
    <email>jhysmc@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hyoen-Cheol Gwon, MD,PhD</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hyoen-Cheol Gwon, MD,PhD</last_name>
      <phone>82-2-3410-3418</phone>
      <email>hcgwon@skku.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>February 7, 2018</last_update_submitted>
  <last_update_submitted_qc>February 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>Hyeon-Cheol Gwon</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>Vasospasm</keyword>
  <keyword>Sarpogrelate</keyword>
  <keyword>Statin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Angina Pectoris, Variant</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarpogrelate</mesh_term>
    <mesh_term>Atorvastatin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01674686
org study id: 2011-12-069
nct id: NCT01674686
lead sponsor: 
has dmc: Yes
The aim of the study was to to evaluate the effect of sarpogrelate, a selective serotonin
      receptor antagonist, and high dose statin on the reduction of coronary spasm in the patients
      with variant angina.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Ergonovine provocation test 12months later
time frame: 1 year later
measure: C-reactive protein lever 12months later
time frame: 1 year
arm group label: A
arm group type: Experimental
description: Sarpogrelate versus placebo
arm group label: B
arm group type: Experimental
description: Atorvastatin 80mg versus no statin or simvastatin 20 mg if LDL > 130 mg/dl
intervention type: Drug
intervention name: Sarpogrelate
description: Sarpogrelate 100mg twice a day
arm group label: A
intervention type: Drug
intervention name: Atorvastatin
description: Atorvastatin 80mg daily
arm group label: B
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Hyeon-Cheol Gwon, MD,PhD
phone: 82-2-3410-3419
email: hcgwon@skku.edu
last name: Jeong Hoon Yang, MD
phone: 82-2-3410-3419
email: jhysmc@gmail.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: Hyeon-Cheol Gwon
investigator title: professor
mesh term: Angina Pectoris, Variant
mesh term: Sarpogrelate
mesh term: Atorvastatin