Role of Plavix in Hemorrhagic and Ischemic Complications of Catheterization.

NCT00421252 | Terminated Phase 4 DMC

• 1 other identifier: 2006P000416
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Myocardial Ischemia; Bleeding

Keywords

clopidogrel; hemorrhagic complication; vascular complication; antiplatelet agent; stenting; percutaneous coronary intervention; risk; ischemia; troponin; sheath size

Outcome Measures

Primary Outcomes (2)

• Cumulative Incidence of major cardiac events

  includes death, MI, TVR, stent throbmosis

  14 days

• Cumulative Incidence of bleeding and major vascular complications

  as described in protocol

  14 days

Secondary Outcomes (3)

• Clinical stent thrombosis

  14 days

• Composite TIMI bleeding endpoint:

  14 days

• Composite vascular complications endpoint:

  14 days

Study Arms (4)

Clopidogrel 600 mg pre-treatment

ACTIVE COMPARATOR

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

No clopidogrel 600 mg pretreatment

ACTIVE COMPARATOR

Patients will receive 600 mg Clopidogrel load after PCI, if performed

Drug: clopidogrel 600 mg

5Fr arterial access sheath

ACTIVE COMPARATOR

Patients will have angiography performed using 5Fr sheath. If PCI required, sheath will be upsized.

Device: arterial access sheath

6Fr arterial access sheath

ACTIVE COMPARATOR

Patients will have angiography performed using 6Fr sheath

Device: arterial access sheath

Interventions

clopidogrel 600 mg DRUG

Clopidogrel load \> 2hrs pre-angiography

Also known as: Plavix 600 mg

Clopidogrel 600 mg pre-treatment; No clopidogrel 600 mg pretreatment

arterial access sheath DEVICE

randomize to 5Fr vs 6Fr

5Fr arterial access sheath; 6Fr arterial access sheath

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients will be excluded if any of the following are present:
• Use of clopidogrel or ticlopidine during the 14 days prior to the scheduled procedure
• Known hypersensitivity to clopidogrel (regardless of desensitization) or to any other components of Plavix
• Contraindication to clopidogrel, including
• Pre-existing bleeding disorder or hematological dyscrasia
• INR \>1.4 immediately prior to the scheduled procedure
• Platelet count \<50 K/uL
• Significant bleeding during the 14 days prior to the scheduled procedure
• Surgery or invasive procedure at a non-compressible location during the 30 days prior to the scheduled procedure
• Anticipated need for surgery or other invasive procedure within 30 days following the scheduled procedure
• Patient states unwillingness to undergo transfusion of red blood cells even in the event of life threatening bleeding
• Unstable cardiac status
• Patient was admitted for a cardiac condition and referred as an inpatient for cardiac catheterization
• Myocardial infarction diagnosed as occurring during the 30 days prior to the scheduled procedure
• Pre-procedure troponin-T \>0.01 ng/mL

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Ischemia; Hemorrhage; Ischemia

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Joseph P Carrozza, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: January 10, 2007
• First Posted: January 11, 2007
• Study Start: January 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: January 1, 2008
• Last Updated: April 14, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)