Does Mean Platelet Volume Change With Clopidogrel

NCT02550301 | Unknown

• 1 other identifier: 14-8707
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Platelets play a major role in thrombus formation and platelet size, measured by Mean Platelet Volume (MPV) correlates with platelet activity. MPV is increased in patients with Myocardial Infarction (MI) and is an independent predictor of adverse events in patients with ST Elevation Myocardial Infarction (STEMI) . Data on MPV in patients with stable angina is limited. Aspirin and clopidogrel are antiplatelet agents administered routinely to patients undergoing PCI and are required for stent patency. MPV is not known to be affected by low dose Aspirin. Treatment with clopidogrel is thought to reduce MPV in-vitro but the magnitude of this reduction in MPV is unclear, especially in patients with stable angina undergoing PCI. An inverse correlation also exists between MPV and platelet count . The investigators aim to assess if a change occurs in MPV (∆ MPV) after routine clopidogrel administration in patients with stable angina undergoing PCI.

Conditions

Stable Angina

Keywords

mean platelet volume

Outcome Measures

Primary Outcomes (1)

• Change in MPV (∆MPV) with clopidogrel in stable angina patients undergoing PCI.

  30 days

Secondary Outcomes (2)

• Change in Platelet count (∆ platelet count) with clopidogrel in stable angina patients

  30 days

• Correlation between ∆MPV and adverse events (readmission and Myocardial Infarction) at 30 days

  30 days

Study Arms (1)

Mean Platelet Volume

4 blood samples (1 pre procedure before clopidogrel loading) and 3 after Percutaneous Coronary Intervention will be drawn to assess the MPV

Other: Mean Platelet Volume

Interventions

Mean Platelet Volume OTHER

Ten milliliters (mls) of blood will be drawn from eligible, consented patients at the time of the admission, collected in ethylenediamine tetraacetic acid (EDTA) tubes, and tested for CBC. Platelets have an average life span that can vary from 8-10 days or 10-36 days. To minimize this bias, three additional MPV samples will be collected on day 1, day 7 and day 30 post PCI.

Mean Platelet Volume

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients who are clopidogrel naïve, electively listed for coronary angiography and Percutaneous Intervention (PCI) at PMCC, Toronto General Hospital (TGH), will be prospectively enrolled in this pilot study

You may qualify if:

• \> 18 years old
• Able to attend for follow up blood tests
• Able to provide written informed consent

You may not qualify if:

• \<18 years of age
• Unable to attend for follow up blood tests on days 1, 7 and 30
• Already on clopidogrel at least 1 day prior to presenting for angiography/PCI
• Those who undergo only diagnostic angiography
• History of Myocardial Infarction (MI) in last 1 year
• Anemia (Hb\<100)
• Abnormal (low or high out of range) platelet counts
• Diabetes Mellitus
• Known liver disease
• Known severe renal impairment (eGFR \<30ml/min/1.73m2)
• Known pregnancy
• On Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) or steroids
• Known connective tissue disease
• Acute ongoing infections or bleeding
• On oral anticoagulant treatment in the last 1 week

Sponsors & Collaborators

• University Health Network, Toronto: lead

Related Publications (14)

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  PMID: 6860588 BACKGROUND

• Pizzulli L, Yang A, Martin JF, Luderitz B. Changes in platelet size and count in unstable angina compared to stable angina or non-cardiac chest pain. Eur Heart J. 1998 Jan;19(1):80-4. doi: 10.1053/euhj.1997.0747.

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  PMID: 16022956 BACKGROUND

• Jagroop IA, Mikhailidis DP. Mean platelet volume is an independent risk factor for myocardial infarction but not for coronary artery disease. Br J Haematol. 2003 Jan;120(1):169-70. doi: 10.1046/j.1365-2141.2003.03983_4.x. No abstract available.

  PMID: 12492596 BACKGROUND

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  PMID: 23786366 BACKGROUND

• Goncalves SC, Labinaz M, Le May M, Glover C, Froeschl M, Marquis JF, O'Brien E, Shukla D, Ruchin P, Sookur D, Ha A, So D. Usefulness of mean platelet volume as a biomarker for long-term outcomes after percutaneous coronary intervention. Am J Cardiol. 2011 Jan 15;107(2):204-9. doi: 10.1016/j.amjcard.2010.08.068. Epub 2010 Dec 2.

  PMID: 21129717 BACKGROUND

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  PMID: 21247392 BACKGROUND

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  PMID: 7282629 BACKGROUND

• Snoep JD, Hovens MM, Eikenboom JC, van der Bom JG, Jukema JW, Huisman MV. Clopidogrel nonresponsiveness in patients undergoing percutaneous coronary intervention with stenting: a systematic review and meta-analysis. Am Heart J. 2007 Aug;154(2):221-31. doi: 10.1016/j.ahj.2007.04.014.

  PMID: 17643570 BACKGROUND

• 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.

  PMID: 12796140 BACKGROUND

• Matetzky S, Shenkman B, Guetta V, Shechter M, Beinart R, Goldenberg I, Novikov I, Pres H, Savion N, Varon D, Hod H. Clopidogrel resistance is associated with increased risk of recurrent atherothrombotic events in patients with acute myocardial infarction. Circulation. 2004 Jun 29;109(25):3171-5. doi: 10.1161/01.CIR.0000130846.46168.03. Epub 2004 Jun 7.

  PMID: 15184279 BACKGROUND

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  PMID: 11972524 BACKGROUND

• Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; Katus HA, Lindahl B, Morrow DA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S. Third universal definition of myocardial infarction. Circulation. 2012 Oct 16;126(16):2020-35. doi: 10.1161/CIR.0b013e31826e1058. Epub 2012 Aug 24. No abstract available.

  PMID: 22923432 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood in EDTA collection tubes to measure Mean Platelet Volume

MeSH Terms

Conditions

Angina, Stable

Interventions

Mean Platelet Volume

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Platelet Function Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cell Size; Cell Physiological Phenomena

Study Officials

• Vladimir Dzavik, MD,FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vladimir Dzavik, MD, FRCPC

CONTACT

+1 416 340 4800; vlad.dzavik@uhn.ca

Chris Overgaard, MD,MSc,FRCPC

CONTACT

+1 416 340 4800; chris.overgaard@uhn.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2015
• First Posted: September 15, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 21, 2015

Record last verified: 2015-09