NCT01365221

Brief Summary

The primary objective of this study is to compare platelet reactivity between patients receiving a loading dose of clopidogrel and a reloading dose of prasugrel to patients receiving only a loading dose of prasugrel.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2010

Typical duration for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2011

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

3.3 years

First QC Date

May 11, 2011

Last Update Submit

September 4, 2020

Conditions

Acute Coronary Syndrome

Keywords

Acute Coronary SyndromeClopidogrelPrasugrel

Outcome Measures

Primary Outcomes (1)

  • The primary objective is to compare platelet reactivity, as assessed by the VerifyNow P2Y12 assay, between patients receiving a loading dose of clopidogrel and a reloading dose of prasugrel to patients receiving only a loading dose of prasugrel.

    Average hospital stay is 24-48 hours.

Secondary Outcomes (1)

  • The secondary objective of this study is to describe rates of bleeding events associated with a loading dose of prasugrel in patients who have already received a loading dose of clopidogrel.

    Average hospital stay is 24-48 hours.

Study Arms (2)

Patients who have received loading dose of clopidogrel

EXPERIMENTAL
Drug: Prasugrel

Patients who have not received loading dose of clopidogrel

ACTIVE COMPARATOR
Drug: Prasugrel

Interventions

PrasugrelDRUG

Patients who have received 600 mg loading dose of clopidogrel will receive a reloading dose of 60 mg prasugrel

Patients who have received loading dose of clopidogrel

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients age 18 or older, of both genders
  • Presenting with an ACS, defined as at least two of the following:
  • Symptoms consistent with myocardial ischemia; ST segment elevation or depression of at least 1 mm in 2 or more contiguous leads on EKG; Cardiac troponin I level above the upper limit of normal.
  • An initial invasive strategy (e.g. early angiography) is planned.
  • No contraindications to prasugrel therapy.

You may not qualify if:

  • Known allergies to aspirin, clopidogrel, or prasugrel.
  • Patient known to be pregnant or lactating.
  • Patient with known history of bleeding diathesis, or currently active bleeding.
  • Platelet count \<100,000/mm3 at the time of enrollment.
  • Hematocrit \<25% at the time of enrollment.
  • On warfarin therapy at the time of PCI, or patient likely to require warfarin therapy post-PCI.
  • Received fibrinolytics within the past 48 hours.
  • Received a glycoprotein IIb/IIIa inhibitor within the past 48 hours, or if a strategy for PCI involving a glycoprotein IIb/IIIa inhibitor is planned.
  • Taking maintenance thienopyridine therapy in the previous 7 days.
  • Known blood transfusion within the preceding 10 days.
  • Patients treated with non-steroidal anti-inflammatory drugs (NSAIDS) within the previous 5 days.
  • Patients with known chronic liver disease.
  • Age greater than 75 years.
  • Body weight less than 60 kg.
  • History of stroke or transient ischemic attack.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

The Heart Center

Huntsville, Alabama, 35801, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Sinai Center for Thrombosis Research

Baltimore, Maryland, 21215, United States

Location

Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Related Publications (1)

  • Lhermusier T, Lipinski MJ, Drenning D, Marso S, Chen F, Torguson R, Waksman R. Switching patients from clopidogrel to prasugrel in acute coronary syndrome: impact of the clopidogrel loading dose on platelet reactivity. J Interv Cardiol. 2014 Aug;27(4):365-72. doi: 10.1111/joic.12139. Epub 2014 Jul 19.

    PMID: 25041356RESULT

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ron Waksman, MD

    Medstar Health Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2011

First Posted

June 3, 2011

Study Start

October 1, 2010

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

September 9, 2020

Record last verified: 2020-09

Locations

US(4)