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Coronary Artery DiseasePPDNCT01103843

Plavix, Prasugrel and Drug Eluting Stents Pilot Trial

A study testing Loading Dose Arm and Maintenance Dose Arm in people with Coronary Artery Disease and Platelet Aggregation Inhibitors, run by St. Francis Hospital, New York at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to determine the level of inhibition of platelet activation of an approved thienopyridine(clopidogrel or prasugrel) and aspirin regimen in the setting of drug eluting coronary stent implantation. Read more about this study

Who is it for?
Ages 21 to 75 years
What is being tested?
Loading Dose Arm and Maintenance Dose Arm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
1 siteUnited States
Study dates
Apr 2010to May 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject presenting for clinically indicated PCI with implantation of at least one drug-eluting stent.
  • No planned use of Glycoprotein IIb/IIIa inhibitors during PCI procedure.
  • Subject must be taking aspirin or enteric coated aspirin 81 mg-325 mg daily.
  • Willing to participate and sign an informed consent.

Who cannot join

  • Subject older than 75 years of age.
  • Subject weight is 60 kg or less.
  • Subject who have received intravenous eptifibatide or tirofiban within 48 hours prior to PCI or abciximab within 14 days before or during PCI.
  • Subject taking warfarin or with clinical indication to resume warfarin post PCI for any indication.
  • Subject currently requiring daily treatment with NSAID or COX2 inhibitors.
  • Subject with a known platelet disorder.
Show all 14Show fewer
  • Subject with known active pathological bleeding or heightened risk of bleeding including but not limited to: gastrointestinal bleeding within 6 months, recent surgery or trauma.
  • Subject with a history of a stroke or TIA
  • Subject with pre-PCI hematocrit or platelet count outside the ranges validated for Verify Now P2Y12 test (33-52% and 119.000-502.000/μL, respectively).
  • Subject with a history of hepatic impairment
  • Subject with known NYHA Class III or greater for heart failure.
  • Inability of subject to provide informed consent.
  • Subject with known hypersensitivity or contraindication to clopidogrel, prasugrel or ASA, which would result in inability of patient to adhere to trial protocol.
  • Presence of valvular heart disease left main coronary artery stenosis or urgent need for CABG.

Trial locations and contacts

1 site in 1 country.

Elizabeth S. Haag, RN, MPA CCRC contact

516 562-6790

elizabeth.haag@chsli.org

Lyn Santiago, RN,CCRC contact

516 562-6790

lyn.santiago@chlsi.org

United States1 site, 1 recruiting
  • St. Francis Hospital

    Roslyn, New York, 11576

    Elizabeth S Haag, RN, MPA,CCRP, 516-562-6790, elizabeth.haag@chsli.org

    Lyn Santiago, RN,CCRC, 516 562-6790, lyn.santiago@chsli.org

    Recruiting

Other trials in United States

About this study

Official title: PPD Trial Pilot Study: Plavix, Prasugrel and Drug Eluting Stents

  • The purpose of this study is to determine the level of inhibition of platelet activation of an approved thienopyridine(clopidogrel or prasugrel) and aspirin regimen in the setting of drug eluting coronary stent implantation.
  • In subjects with high residual levels of platelet reactivity after receiving either a maintenance or loading dose of either clopidogrel or prasugrel, a cross over of thienopyridine treatment to the alternate medication will occur.
  • The study tests the hypothesis that adequate platelet inhibition will occur in subjects who have high levels of platelet reactivity and are subsequently switched from clopidogrel to prasugrel(loading or maintenance dose) without increased episodes of bleeding or MACE events at discharge and 30 days post Percutaneous Coronary Intervention (PCI).
Being tested
Loading Dose Arm, Maintenance Dose Arm
Keywords
Coronary artery disease, clopidogrel, prasugrel, Verify Now, PRU measurements, Drug eluting stents (EDS), P2Y12, Platelet reactivity
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Loading Dose ArmDrug

    Also called clopidogrel, prasugrel, Verify now P2Y12 platelet assay

    Subjects who are thienopyridine naive will be randomized 1:1 to either clopidogrel 600 mg or prasugrel 60 mg loading dose at the time of PCI. A Verify Now P2Y12 platelet assay will measure platelet reactivity. Cross over to loading dose and maintenance dose of alternate medication will occur based on level of platelet reactivity.

  • Maintenance Dose ArmDrug

    Also called thienoyridine, Verify now P2Y12, prasugrel, clopidogrel

    Verify Now P2Y12 platelet assay will measure platelet reactivity. Cross over to a loading dose and maintenance dose of alternate medication will occur based on level of platelet reactivity.

Study groups in NCT01103843
Study groupRoleWhat they receive
Maintenance Dose ArmActive comparatorOpen label clopidogrel 75 mg daily or prasugrel 10 mg daily
Receives: Drug: Maintenance Dose Arm
Loading Dose ArmActive comparatorClopidogrel 600 mg or Prasugrel 60 mg at time of PCI.
Receives: Drug: Loading Dose Arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in platelet reactivity after switching medication regimen of two thienopyridines- clopidogrel and prasugrel

    Platelet reactivity will be measured using the Accumetrics Verify Now P2Y12 platelet assay

    Measured: 4 hours post medicaton administration

Secondary outcomes (2)
  1. Occurrence of all bleeding events for subjects enrolled into the trial

    All bleeding events will be observed, reported and adjudicated by the DSMB

    Measured: 24 hours post PCI or at time of discharge and 30 days post PCI

  2. Occurrence of all MACE events for subjects enrolled into the trial

    All bleeding events will be observed, reported and adjudicated by the DSMB

    Measured: 24 hours post PCI or at time of discharge and 30 days post PCI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionApr 2011 (estimated)
  4. Study completionMay 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01103843
Sponsor's protocol ID
10-006
Acronym
PPD
Status last verified
Apr 2010
First submitted
14 Apr 2010
Last updated
15 Apr 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Brandt JT, Close SL, Iturria SJ, Payne CD, Farid NA, Ernest CS 2nd, Lachno DR, Salazar D, Winters KJ. Common polymorphisms of CYP2C19 and CYP2C9 affect the pharmacokinetic and pharmacodynamic response to clopidogrel but not prasugrel. J Thromb Haemost. 2007 Dec;5(12):2429-36. doi: 10.1111/j.1538-7836.2007.02775.x. Epub 2007 Sep 26.

    PubMed 17900275
  • Neubauer H, Lask S, Engelhardt A, Mugge A. How to optimise clopidogrel therapy? Reducing the low-response incidence by aggregometry-guided therapy modification. Thromb Haemost. 2008 Feb;99(2):357-62. doi: 10.1160/TH07-10-0624.

    PubMed 18278186
  • Gurbel PA, Bliden KP, Hiatt BL, O'Connor CM. Clopidogrel for coronary stenting: response variability, drug resistance, and the effect of pretreatment platelet reactivity. Circulation. 2003 Jun 17;107(23):2908-13. doi: 10.1161/01.CIR.0000072771.11429.83. Epub 2003 Jun 9.

    PubMed 12796140
  • Ferguson AD, Dokainish H, Lakkis N. Aspirin and clopidogrel response variability: review of the published literature. Tex Heart Inst J. 2008;35(3):313-20.

    PubMed 18941611
  • Simon T, Verstuyft C, Mary-Krause M, Quteineh L, Drouet E, Meneveau N, Steg PG, Ferrieres J, Danchin N, Becquemont L; French Registry of Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) Investigators. Genetic determinants of response to clopidogrel and cardiovascular events. N Engl J Med. 2009 Jan 22;360(4):363-75. doi: 10.1056/NEJMoa0808227. Epub 2008 Dec 22.

    PubMed 19106083
  • Farid NA, Kurihara A, Wrighton SA. Metabolism and disposition of the thienopyridine antiplatelet drugs ticlopidine, clopidogrel, and prasugrel in humans. J Clin Pharmacol. 2010 Feb;50(2):126-42. doi: 10.1177/0091270009343005. Epub 2009 Nov 30.

    PubMed 19948947
  • Wiviott SD, Braunwald E, McCabe CH, Montalescot G, Ruzyllo W, Gottlieb S, Neumann FJ, Ardissino D, De Servi S, Murphy SA, Riesmeyer J, Weerakkody G, Gibson CM, Antman EM; TRITON-TIMI 38 Investigators. Prasugrel versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2007 Nov 15;357(20):2001-15. doi: 10.1056/NEJMoa0706482. Epub 2007 Nov 4.

    PubMed 17982182
  • Wiviott SD, Trenk D, Frelinger AL, O'Donoghue M, Neumann FJ, Michelson AD, Angiolillo DJ, Hod H, Montalescot G, Miller DL, Jakubowski JA, Cairns R, Murphy SA, McCabe CH, Antman EM, Braunwald E; PRINCIPLE-TIMI 44 Investigators. Prasugrel compared with high loading- and maintenance-dose clopidogrel in patients with planned percutaneous coronary intervention: the Prasugrel in Comparison to Clopidogrel for Inhibition of Platelet Activation and Aggregation-Thrombolysis in Myocardial Infarction 44 trial. Circulation. 2007 Dec 18;116(25):2923-32. doi: 10.1161/CIRCULATIONAHA.107.740324. Epub 2007 Dec 3.

    PubMed 18056526
  • Li YG, Ni L, Brandt JT, Small DS, Payne CD, Ernest CS 2nd, Rohatagi S, Farid NA, Jakubowski JA, Winters KJ. Inhibition of platelet aggregation with prasugrel and clopidogrel: an integrated analysis in 846 subjects. Platelets. 2009 Aug;20(5):316-27. doi: 10.1080/09537100903046317.

    PubMed 19637095
  • Mega JL, Close SL, Wiviott SD, Shen L, Hockett RD, Brandt JT, Walker JR, Antman EM, Macias WL, Braunwald E, Sabatine MS. Cytochrome P450 genetic polymorphisms and the response to prasugrel: relationship to pharmacokinetic, pharmacodynamic, and clinical outcomes. Circulation. 2009 May 19;119(19):2553-60. doi: 10.1161/CIRCULATIONAHA.109.851949. Epub 2009 May 4.

    PubMed 19414633
  • Payne CD, Li YG, Brandt JT, Jakubowski JA, Small DS, Farid NA, Salazar DE, Winters KJ. Switching directly to prasugrel from clopidogrel results in greater inhibition of platelet aggregation in aspirin-treated subjects. Platelets. 2008 Jun;19(4):275-81. doi: 10.1080/09537100801891640.

    PubMed 18569863
  • Godino C, Mendolicchio L, Figini F, Latib A, Sharp AS, Cosgrave J, Calori G, Cera M, Chieffo A, Castelli A, Maseri A, Ruggeri ZM, Colombo A. Comparison of VerifyNow-P2Y12 test and Flow Cytometry for monitoring individual platelet response to clopidogrel. What is the cut-off value for identifying patients who are low responders to clopidogrel therapy? Thromb J. 2009 May 6;7:4. doi: 10.1186/1477-9560-7-4.

    PubMed 19419580

Questions about this trial

What is this clinical trial studying?

A study testing Loading Dose Arm and Maintenance Dose Arm in people with Coronary Artery Disease and Platelet Aggregation Inhibitors, run by St. Francis Hospital, New York at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Elizabeth S. Haag, RN, MPA CCRC (516 562-6790, elizabeth.haag@chsli.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in platelet reactivity after switching medication regimen of two thienopyridines- clopidogrel and prasugrel (time frame: 4 hours post medicaton administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01103843, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2010.

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