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Role of Plavix in Hemorrhagic and Ischemic Complications of Catheterization.

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. Identifier: NCT00421252
Recruitment Status : Terminated (Difficult to enroll patients; limited resources available)
First Posted : January 11, 2007
Last Update Posted : April 14, 2017
Information provided by (Responsible Party):
Donald Cutlip, Beth Israel Deaconess Medical Center

Brief Summary:

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 or disease Intervention/treatment Phase
Coronary Artery Disease Myocardial Ischemia Bleeding Drug: clopidogrel 600 mg Device: arterial access sheath Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (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.
Actual Study Start Date : January 2007
Actual Primary Completion Date : November 2007
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Clopidogrel 600 mg pre-treatment
Patients will receive 600 mg Clopidogrel load >2 hours pre-angiography with possibility for ad hoc PCI based on angiographic results
Drug: clopidogrel 600 mg
Clopidogrel load > 2hrs pre-angiography
Other Name: Plavix 600 mg

Active Comparator: No clopidogrel 600 mg pretreatment
Patients will receive 600 mg Clopidogrel load after PCI, if performed
Drug: clopidogrel 600 mg
Clopidogrel load > 2hrs pre-angiography
Other Name: Plavix 600 mg

Active Comparator: 5Fr arterial access sheath
Patients will have angiography performed using 5Fr sheath. If PCI required, sheath will be upsized.
Device: arterial access sheath
randomize to 5Fr vs 6Fr

Active Comparator: 6Fr arterial access sheath
Patients will have angiography performed using 6Fr sheath
Device: arterial access sheath
randomize to 5Fr vs 6Fr

Primary Outcome Measures :
  1. Cumulative Incidence of major cardiac events [ Time Frame: 14 days ]
    includes death, MI, TVR, stent throbmosis

  2. Cumulative Incidence of bleeding and major vascular complications [ Time Frame: 14 days ]
    as described in protocol

Secondary Outcome Measures :
  1. Clinical stent thrombosis [ Time Frame: 14 days ]
    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

  2. Composite TIMI bleeding endpoint: [ Time Frame: 14 days ]
    hemoglobin drop >3 g/dL, RBC transfusion, or intracranial hemorrhage

  3. Composite vascular complications endpoint: [ Time Frame: 14 days ]
    retroperitoneal bleeding, pseudoaneurysm, AV fistula, or vascular injury requiring vascular surgery or ultrasound guided therapy

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00421252

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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
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Principal Investigator: Joseph P Carrozza, MD Beth Israel Deaconess Medical Center

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Responsible Party: Donald Cutlip, Professor of Medicine, Beth Israel Deaconess Medical Center Identifier: NCT00421252    
Other Study ID Numbers: 2006P000416
First Posted: January 11, 2007    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans to share data
Keywords provided by Donald Cutlip, Beth Israel Deaconess Medical Center:
hemorrhagic complication
vascular complication
antiplatelet agent
percutaneous coronary intervention
sheath size
Additional relevant MeSH terms:
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Myocardial Ischemia
Coronary Artery Disease
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs