This trial is active, not recruiting.

Conditions peripheral vascular disease, peripheral artery disease, carotid stenosis, aortic aneurysm, abdominal, aortic aneurysm, thoracic, amputation, wound, embolism and thrombosis, aortic aneurysm
Sponsor New York University School of Medicine
Collaborator American Heart Association
Start date June 2013
End date December 2016
Trial size 200 participants
Trial identifier NCT01897103, 12-03123


The proposed PIVOTAL study will examine a panel of platelet/coagulation activity markers during the perioperative period. The goal is to develop a clinically useful assessment of platelet/coagulation activity for risk stratification that may ultimately serve as a target for therapeutic intervention. This study will enroll 200 patients with peripheral artery disease undergoing vascular surgery. PIVOTAL is funded by American Heart Association and is scheduled to begin enrollment in July 2013 for approximately two years.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Platelet Activity
time frame: two years

Secondary Outcomes

Perioperative Events
time frame: Two-years

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: - Subjects undergoing non emergent vascular surgery - Use of aspirin within 48 hours prior to surgery - Age > 21 years of age - Able and willing to provide written informed consent for the study Exclusion Criteria: - Use of any anticoagulant (Coumadin, heparin) within 24 hours to surgery - Use of any Nonsteroidal Antiinflammatory Drug (NSAID) (such as ibuprofen, naproxen, etc.) within 72 hours - Thrombocytopenia (platelet count<100) or Thrombocytosis (platelet count>500), - Anemia (hemoglobin<9), - Severe kidney disease (CrCl<30ml/min), - Any known hemorrhagic diathesis.

Additional Information

Official title Platelet Activity in Vascular Surgery
Principal investigator Jeffrey S Berger, MD, MS, FAHA, FACC
Description To describe platelet activity among PAD subjects undergoing vascular surgery. To determine whether preoperative platelet activity measurements are independently associated with perioperative cardiovascular events. To identify demographic, clinical, and surgical factors associated with postoperative platelet activity measurements in patients with established PAD.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by New York University School of Medicine.