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Trial record 99 of 509 for:    ASPIRIN AND P2

Antiplatelet Therapy Following Stent Implantation (Anti-Clot)

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.
 
ClinicalTrials.gov Identifier: NCT02051361
Recruitment Status : Completed
First Posted : January 31, 2014
Last Update Posted : May 18, 2016
Sponsor:
Information provided by (Responsible Party):
Elpen Pharmaceutical Co. Inc.

Brief Summary:
Coronary artery stents, particularly drug-eluting stents (DES), are used in the majority of patients who undergo percutaneous coronary intervention (PCI) to improve symptoms in patients with obstructive coronary artery disease. They function both to prevent abrupt closure of the stented artery soon after the procedure as well as to lower the need for repeat revascularization compared to balloon angioplasty alone . Stent restenosis and stent thrombosis are potential complications of coronary artery stenting; their incidence is highest in the first year after PCI. Stent restenosis, which occurs more frequently with bare metal stents (BMS) than DES, may occasionally present as an acute myocardial infarction (MI). Stent thrombosis is an uncommon but serious complication that often presents as death and is almost always accompanied by MI, usually with ST-segment elevation. Patients are commonly treated with dual antiplatelet therapy (DAPT) for the recommended duration for the particular stent. DAPT (aspirin plus platelet P2Y12 receptor blocker) and significantly lowers the risk of stent thrombosis.

Condition or disease
Acute Myocardial Infarction Coronary Syndrome Angina, Unstable

Show Show detailed description

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Study Type : Observational
Actual Enrollment : 900 participants
Time Perspective: Prospective
Official Title: Open Label, Non Interventional, Multi-center, Observational Study to Assess the Antiplatelet Treatment Pre and Post-operatively of Stent Implantation
Study Start Date : April 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Clopidogrel

Group/Cohort
Clopidogrel treated patients
Patients pre and post operatively following stent implantation treated with clopidogrel and aspirin



Primary Outcome Measures :
  1. Number of Major Adverse Cardiac Events (MACEs) [ Time Frame: 6 months ]

    All Death,

    • Cardiac death,
    • Myocardial infarction,
    • Stroke,
    • Target vessel revascularization (TVR)
    • Bleeding event
    • In-stent restenosis (ISR)


Secondary Outcome Measures :
  1. Number of missed daily doses [ Time Frame: 6 months ]
    Compliance to antiplatelet treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients on clopidogrel treatment following stent implantation
Criteria

Inclusion Criteria:

  • Patients in whom planned or unplanned stent implantation
  • Ages Eligible for Study: 18 Years and older
  • Genders Eligible for Study: Both
  • Acute coronary syndrome
  • ST-segment elevation MI (STEMI)
  • non ST-segment elevation MI (STEMI)
  • Stable angina pectoris and or/ documented myocardial ischemia
  • Instable angina pectoris and or/ documented myocardial ischemia
  • De-novo stenosis of coronary artery with a degree of stenosis between 50% and 99%, that is accessible to PTCA
  • Patients on pre-defined group of clopidogrel treatment during and after DES implantation
  • Willingness and ability to adhere to the study conditions
  • Written informed consent after patient information

Exclusion Criteria:

  • Known severe arrhythmias that necessitate a long term antiarrhythmic therapy
  • Pericarditis
  • Intracardiac thrombus
  • Bacterial endocarditis
  • Patients with contraindication for aortocoronary bypass operation,
  • Contraindication to antiplatelet therapy
  • Non-cardiac co-morbid conditions that may result in protocol non-compliance (per site investigator's medical judgment).
  • Bleeding diathesis
  • Thrombocytopenia (<150 000/mm3)
  • Recent (<6 months) gastrointestinal bleeding
  • Recent stroke within 6-months
  • Concurrent organ damage (creatinine level > 2.0mg/dL or AST and ALT > 3 times upper normal reference values)
  • Patients with left main stem stenosis (>50% by visual estimate)
  • History of allergy to aspirin
  • Inability, to understand sense and purpose of the study
  • Patients not willing to keep the conditions of the study

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): NCT02051361


Locations
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Greece
KAT Hospital
Athens, Greece
Sponsors and Collaborators
Elpen Pharmaceutical Co. Inc.
Investigators
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Study Director: Sotirios Patsilinakos, MD, PhD Agia Olga Konstantopoulion hospital of Athens
Principal Investigator: Nikolaos Kafkas, MD Cardiologist KAT Hospital of Athens

Additional Information:
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Responsible Party: Elpen Pharmaceutical Co. Inc.
ClinicalTrials.gov Identifier: NCT02051361    
Other Study ID Numbers: 2013-CLOBES-EL-41
First Posted: January 31, 2014    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Elpen Pharmaceutical Co. Inc.:
DAT = Dual Antiplatelet Treatment
Major Cardiac Adverse Events
Additional relevant MeSH terms:
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Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Myocardial Infarction
Angina, Unstable
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Clopidogrel
Platelet Aggregation Inhibitors
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs