Role of Plavix in Hemorrhagic and Ischemic Complications of Catheterization.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2008 by Beth Israel Deaconess Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00421252
First received: January 10, 2007
Last updated: March 10, 2008
Last verified: March 2008
  Purpose

Patients who have stents placed in their coronary arteries require treatment with at least two medications to prevent platelets from sticking to the stainless steel stent and forming a blood clot that can result in a heart attack. The 2 anti-platelet medications used for most patients with stents are aspirin and clopidogrel (Plavix). These are usually prescribed for 1-12 months (the length of time depends on the number and types of stents implanted). Although the typical long-term dose of clopidogrel is 75 mg by mouth once daily, a larger dose (known as a loading dose) is usually given at the start of treatment to help the medication take effect more quickly.

Prior to January 2006, most patients at the Beth Israel Deaconess Medical Center (BIDMC) who were undergoing PCI and who had not already been taking clopidogrel would receive a loading dose of 300-600 mg of clopidogrel in the cardiac catheterization procedure room immediately after the angioplasty and stenting portion of the procedure. However, several recent studies suggest that administering clopidogrel 600 mg at least two hours prior to an angioplasty procedure can reduce the rate of complications afterwards (especially reducing the chances of detectable damage to the heart muscle).

The main purpose of this study is to see whether giving a loading dose of clopidogrel 600 mg to outpatients scheduled to undergo cardiac catheterization with coronary angiography can decrease the risk of procedure-related complications during the 14 days following the cardiac catheterization compared to a strategy of giving clopidogrel 600 mg after the procedure only to those who undergo angioplasty. We will focus our attention particularly on detecting damage to heart muscle following angioplasty (which might be expected to improve with a loading dose of clopidogrel before the procedure) and on bleeding and other groin complications (which might worsen with clopidogrel loading before the procedure).

The drug clopidogrel has been approved by the Food and Drug Administration (FDA) for use in patients with a recent or ongoing heart attack, narrowings in major blood vessels outside the heart, or recent stroke with a loading dose of 300 mg followed by 75 mg once daily. It has been used in several large studies with a loading dose of 600 mg without a significant increase in major adverse effects. However, we do not yet know if it is useful or safe when given as a loading dose of 600 mg before cardiac catheterization for outpatients with stable symptoms and who are not thought to be in the midst of a heart attack.


Condition Intervention Phase
Coronary Artery Disease
Myocardial Ischemia
Bleeding
Drug: clopidogrel 600 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Pre-Treatment With 600mg of Clopidogrel (Plavix) on the Incidence of Ischemic and Hemorrhagic Complications in Patients Undergoing Elective Percutaneous Coronary Revascularization.--Prospective Randomized Trial.

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • All endpoints will be assessed at 14 days post-procedure (and divided for analytical purposes into in-hospital and post-discharge events). The events of interest include:
  • All cause mortality
  • Myocardial infarction (American College of Cardiology National Cardiovascular Data Registry CathPCI Registry definition of CKMB >3 times the upper limit of normal, i.e. >30 ng/mL)
  • Myocardial necrosis (troponin-T above the limit diagnostic for myocardial necrosis/infarction, i.e., >0.10 ng/mL)
  • Clinically driven repeat revascularization of the target vessel
  • Angiographically documented stent thrombosis
  • Fall in hemoglobin by >3 g/dL from the most recent pre-procedure hemoglobin value
  • Any bleeding requiring transfusion of packed RBCs
  • Intracranial hemorrhage documented on an imaging study
  • Retroperitoneal hemorrhage documented on an imaging study or on surgical exploration
  • Pseudoaneurysm documented on imaging study or on surgical exploration
  • Arteriovenous (AV) fistula documented on imaging study or on surgical exploration
  • Vascular injury requiring vascular surgery and/or ultrasound guided therapy (including compression and/or thrombin injection)
  • Aprotonin use in patients requiring urgent cardiac surgery.

Secondary Outcome Measures:
  • Composite endpoints to be evaluated include:
  • The primary composite endpoint of any death, myocardial infarction, or myocardial necrosis
  • Clinical stent thrombosis, which includes angiographically documented stent thrombosis, any acute coronary syndrome post-PCI that cannot be attributed to a non-target vessel, or any cardiac death in which angiographic stent thrombosis cannot be exclude
  • Composite TIMI bleeding endpoint: hemoglobin drop >3 g/dL, RBC transfusion, or intracranial hemorrhage
  • Composite vascular complications endpoint: retroperitoneal bleeding, pseudoaneurysm, AV fistula, or vascular injury requiring vascular surgery or ultrasound guided therapy

Estimated Enrollment: 600
Study Start Date: January 2007
Estimated Study Completion Date: September 2008
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient less than 18 years of age
  2. Patient referred as an outpatient for elective cardiac catheterization with coronary angiography and ad hoc percutaneous coronary intervention (if coronary anatomy suitable)
  3. Patient has stable angina or a stress test suggestive of ischemia and/or prior myocardial infarction
  4. Anticipated femoral arterial approach for the cardiac catheterization procedure
  5. Patient provides written informed consent

Exclusion Criteria:

Patients will be excluded if any of the following are present:

  1. Use of clopidogrel or ticlopidine during the 14 days prior to the scheduled procedure
  2. Known hypersensitivity to clopidogrel (regardless of desensitization) or to any other components of Plavix
  3. Contraindication to clopidogrel, including

    1. Pre-existing bleeding disorder or hematological dyscrasia
    2. INR >1.4 immediately prior to the scheduled procedure
    3. Platelet count <50 K/uL
    4. Significant bleeding during the 14 days prior to the scheduled procedure
    5. Surgery or invasive procedure at a non-compressible location during the 30 days prior to the scheduled procedure
    6. Anticipated need for surgery or other invasive procedure within 30 days following the scheduled procedure
    7. Patient states unwillingness to undergo transfusion of red blood cells even in the event of life threatening bleeding
  4. Unstable cardiac status

    1. Patient was admitted for a cardiac condition and referred as an inpatient for cardiac catheterization
    2. Myocardial infarction diagnosed as occurring during the 30 days prior to the scheduled procedure
    3. Pre-procedure troponin-T >0.01 ng/mL
    4. Unstable angina

    i. Ischemic symptoms at rest ii. Ischemic symptoms with mild exertion (e.g., walking one to two level blocks or climbing one flight of stairs) e. Pre-procedure electrocardiogram with ST segment changes indicative of ongoing myocardial injury or ischemia

  5. Chronic renal failure (which may raise troponin-T levels)

    1. Patient currently undergoing dialysis
    2. Serum creatinine >2 mg/dL
    3. Estimated glomerular filtratation rate (eGFR using the MDRD formula) <45 mL/min/1.73 m2
  6. Procedural factors

    1. Patient does not require coronary angiography as part of the scheduled cardiac catheterization
    2. Patient is not a candidate for percutaneous coronary intervention during the same procedure as the diagnostic coronary angiography
    3. Anticipated need for arterial access using brachial, radial or other non-femoral approach
    4. Anticipated need to access the femoral artery via a femoral bypass graft
    5. Anticipated need for an arterial sheath 6 French in size or larger (e.g., planned evaluation of aortic stenosis or hypertrophic cardiomyopathy)
    6. Anticipated need for heparin anticoagulation during the diagnostic cardiac catheterization procedure (e.g., crossing a stenosed aortic valve with a 0.035" wire, planned intra-vascular ultrasound or pressure wire study)
  7. Woman of child-bearing potential who does not have a negative pregnancy test immediately prior to the scheduled procedure
  8. Participation in another non-observational clinical study that has not yet completed all mandatory follow-up (i.e., patients who are participating in a "natural history" observational registry where no active therapy is being investigated may participate)
  9. Prior participation in this study
  10. Inability to provide written informed consent or demonstrate understanding of the risks and benefits associated with participation in this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00421252

Contacts
Contact: Joseph P Carrozza, MD 617-632-7455 jcarrozz@bidmc.harvard.edu
Contact: Joanna J Wykrzykowska, MD 617-767-5343 jwykrzyk@bidmc.harvard.edu

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02215
Sub-Investigator: Joanna J Wykrzykowska, MD         
Sub-Investigator: Kalon Ho, MD         
Sub-Investigator: Donald Cutlip, MD         
Sub-Investigator: Usman Khokhar, MD         
Sub-Investigator: Laurel Donnell-Fink, BA         
Sub-Investigator: Meghan York, MD         
Sub-Investigator: JoEllyn Abraham, MD         
Sub-Investigator: Deborah Jones, RN         
Sub-Investigator: Paula Rooney, RN         
Sub-Investigator: Theresa Bishop, RN         
Principal Investigator: Joseph P Carrozza, MD         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Joseph P Carrozza, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00421252     History of Changes
Other Study ID Numbers: 2006P-000416
Study First Received: January 10, 2007
Last Updated: March 10, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
clopidogrel
hemorrhagic complication
vascular complication
antiplatelet agent
stenting
percutaneous coronary intervention
risk
ischemia
troponin
sheath size

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Clopidogrel
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014