Tailoring Of Platelet Inhibition to Avoid Stent Thrombosis

NCT00914368 | Completed Phase 2

• 1 other identifier: U-08-002
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to establish a cut off level of platelet inhibition that separates patients with or without previous stent occlusion with acute clinical onset while on aspirin and clopidogrel treatment within 6 months after coronary stenting for coronary artery disease.

Conditions

Coronary Artery Disease; Myocardial Infarction; Stent Thrombosis; Heart Diseases; Acute Coronary Syndrome

Keywords

Platelet Aggregation Inhibitors; Aspirin; Clopidogrel; Pathologic Processes; Disease; Therapeutic Uses; Syndrome; Hematologic Agents; Cardiovascular Diseases; Pharmacologic Actions

Outcome Measures

Primary Outcomes (1)

• VerifyNow P2Y12 (PRU)

  Within 6 months

Secondary Outcomes (1)

• VASP (PRI, %)

  Within 6 months

Study Arms (3)

1

ACTIVE COMPARATOR

Patients with previously experienced stent thrombosis while on dual antiplatelet treatment within 6 months after coronary stenting for coronary artery disease

Drug: Clopidogrel

2

ACTIVE COMPARATOR

Patients with previously experienced myocardial infarction while on dual antiplatelet treatment within 6 months after coronary stenting for coronary artery disease

Drug: Clopidogrel

3

ACTIVE COMPARATOR

Patients without previously experienced myocardial infarction or stent thrombosis 6 within months after coronary stenting for coronary artery disease(matched controls for group 1 and 2)

Drug: Clopidogrel

Interventions

Clopidogrel DRUG

Patients not already on clopidogrel treatment a loading dose of clopidogrel 600 mg followed by a maintenance dose of 75 mg once daily will be administered.

Also known as: Plavix

1; 2; 3

Eligibility Criteria

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

You may qualify if:

• Provide signed written informed consent.
• Male or female patients above 18 years old.
• Previous PCI and coronary stenting for coronary artery disease
• Previous (after coronary stenting) or current dual antiplatelet treatment (aspirin 75 mg once daily (o.d) and clopidogrel 75 mg o.d). All patients need to be on treatment with aspirin 75 mg once daily at least seven days prior to enrollment.
• Experienced one of the following alternatives:
• Stent thrombosis within 6 months of PCI while on dual antiplatelet treatment; OR
• Experienced MI within 6 month after coronary stenting while on dual antiplatelet treatment; OR
• No experience of stent thrombosis or MI for at least 6 months and until visit 1 (matched control)

You may not qualify if:

• Women who are known to be pregnant, who have given birth within the past 90 days, or who are breastfeeding.
• Enrolled in either another investigational drug study or in another investigational study of an approved drug within 30 days prior to Visit 1 of the current study.
• Known allergies or intolerance to aspirin and/or thienopyridines (clopidogrel or ticlopidine).
• Significant active neuropsychiatric disease, alcohol abuse or drug abuse, in the investigator's opinion.
• UCR or Accumetrics employees or investigator site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
• Subjects with unstable coronary artery disease, defined as new, increased, or rest angina at screening.
• Subjects with significant hypertension (systolic blood pressure \> 180 mm Hg or diastolic blood pressure \>110 mmHg) at the time of screening.
• Any known contraindication to treatment with an anticoagulant or antiplatelet agent.
• Prior history or presence of significant bleeding disorders (for example,hematemesis, melena, severe or recurrent epistaxis, hemoptysis, hematuria, or intraocular bleeding)
• Prior history or clinical suspicion of cerebral vascular malformations
• Prior history of abnormal bleeding tendency (i.e. prolonged bleeding on dental extraction, tonsillectomy, or previous surgical procedure).
• Personal or family history of coagulation or bleeding disorders.
• Thrombocytopenia (platelet count \< 100,000/mm3) or thrombocytosis (platelet count \> 500,000/mm3).
• History of major surgery, severe trauma, organ biopsy within 3 months prior to enrollment.
• The use (or planned use) of other antiplatelet agents (besides aspirin and clopidogrel), anticoagulant or fibrinolytic agents.

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Uppsala Clinical Research Center

Uppsala, 75185, Sweden

Location

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction; Heart Diseases; Acute Coronary Syndrome; Pathologic Processes; Disease; Syndrome; Cardiovascular Diseases

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathological Conditions, Signs and Symptoms; Necrosis

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

• Lars Wallentin, MD, PhD

  Uppsala University, Uppsala Clinical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 29, 2009
• First Posted: June 5, 2009
• Study Start: January 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: April 13, 2010

Record last verified: 2009-09

Locations

SE (1)