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Trial record 1 of 4 for:    TCAP
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Ticagrelor in Severe Community Acquired Pneumonia (TCAP)

This study has been terminated.
(poor enrollment, unable to meet recruitment goals)
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Gordon Bernard, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:
NCT01998399
First received: November 15, 2013
Last updated: February 16, 2017
Last verified: February 2016
  Purpose
The purpose of this study is to determine if the drug ticagrelor will be an effective treatment for patients with severe community acquired pneumonia. The primary objective is to reduce all-cause mortality in the ticagrelor group compared to the placebo group.

Condition Intervention Phase
Community Acquired Pneumonia, Severe Drug: Ticagrelor Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of Ticagrelor for Severe Community Acquired Pneumonia

Resource links provided by NLM:


Further study details as provided by Gordon Bernard, Vanderbilt University Medical Center:

Primary Outcome Measures:
  • All-cause Mortality [ Time Frame: 90 day ]
    Alive or dead on day 90


Secondary Outcome Measures:
  • Shock Free Days [ Time Frame: 14 days ]
    Not requiring pressor support for hypotension

  • Ventilator Free Days [ Time Frame: 28 days ]
  • In-hospital Mortality [ Time Frame: Throughout hospitalization ]
    Did the patient die during the hospitalization?

  • Hospital Free Days [ Time Frame: 60 days ]
    Number of days the patient is not in the hospital

  • Stroke [ Time Frame: 90 days ]
    Did the patient develop a stroke during the 90 day study?

  • Composite Endpoint: Stroke, Myocardial Infarct, Mortality [ Time Frame: 90 days ]
  • Myocardial Infarction [ Time Frame: 90 days ]
    Did the patient have a myocardial infarction during the 90 day study?


Other Outcome Measures:
  • Time to Initiation of Unassisted Breathing [ Time Frame: 90 days ]
    Only in patients on mechanical ventilation and assuming patient achieves 48 consecutive hours of unassisted breathing

  • Need for Re-instituting Assisted or Mechanical Ventilation After Achieving 48 Consecutive Hours of Unassisted Breathing or Comfort Care Chosen (Withdrawal of Support) [ Time Frame: 90 days ]
    Yes, No

  • Need for Dialysis [ Time Frame: 90 days ]
    Yes, No

  • ICU Length of Stay [ Time Frame: 90 days ]
    Includes ICU readmission if during same hospital stay

  • Hospital Length of Stay [ Time Frame: 90 days ]
    In days

  • Discharge Disposition [ Time Frame: 90 days ]
    (Home, other facility, with or without assisted ventilation)


Enrollment: 25
Study Start Date: August 2014
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ticagrelor
Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days
Drug: Ticagrelor
Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days
Other Name: Brilinta
Placebo Comparator: Placebo
Placebo 180 mg loading dose followed by 90 mg BID for 90 days.
Drug: Placebo
Placebo 180 mg loading dose followed by 90 mg BID for 90 days.

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Patients will have new "severe" CAP as defined by

a. New (within 72 hours of hospital admission) radiographic finding consistent with pneumonia and admission or planned admission to an ICU for: i. Mechanical Ventilation (invasive or non-invasive) OR ii. Vasopressors (dobutamine and phosphodiesterase are not considered vasopressors for this criteria) OR iii. ICU admission due to severe respiratory distress or arterial desaturation. b. At least two of the following; i. recent increase in dyspnea ii. increased sputum production iii. change of character of sputum iv. White Blood Cells > 12,000 or < 4,000 cells/mm3 or >10% bands v. Body temperature >38ºC or <36ºC (any route)

Exclusion Criteria:

  1. More than 72 hours have passed since meeting required inclusion criteria.
  2. Development of pneumonia after 72 hours of current hospitalization.
  3. Underlying disease likely to cause mortality within 90 days of randomization.
  4. A resident in a hospital, not nursing home, within 30 days prior to development of pneumonia.
  5. Patients who are moribund (not expected to live for more than 48 hours).
  6. No consent/inability to obtain consent from patient or surrogate.
  7. Patient's physician is unwilling to have patient enter the study.
  8. Age less than 50 years.
  9. Pregnancy.
  10. Breast feeding.
  11. Underlying immunodeficiency (e.g. HIV, neutropenia, active hematologic malignancy, functional or anatomical asplenia and hypogammaglobulinemia).
  12. Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she will receive all supportive care except for attempts at resuscitation from cardiac arrest).
  13. Unable to receive or unlikely to absorb enteral study drug (e.g., patients with partial or complete mechanical bowel obstruction, intestinal ischemia, infarction, and short bowel syndrome).
  14. Hepatic impairment

    a. Child Pugh score > 7 using data from outpatient setting

  15. Conditions that increase the risk of bleeding, e.g.:

    1. Surgery or the likely need for surgery during study, or evidence of active bleeding postoperatively (ICU procedures such as line placement, tracheostomy and chest tubes are not to be considered for this exclusion);
    2. A history of severe head trauma requiring hospitalization or intra-cranial surgery within 3 months;
    3. Any history of intracerebral arteriovenous malformation, cerebral aneurysm, or mass lesions of the central nervous system, hemorrhagic stroke or intracranial hemorrhage, or congenital bleeding diathesis;
    4. Gastrointestinal bleeding within 6 weeks before the study unless a corrective procedure has been performed;
    5. Recent trauma considered to increase the risk of bleeding.
  16. Chronic renal disease requiring renal replacement therapy.
  17. Creatinine > 3 mg/dL.
  18. Platelet count < 50,000 /mm3.
  19. Use of a P2Y12 inhibitor within the 3 months prior to randomization or physician intent to initiate one of the CYP3A inhibitors, e.g. ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, atazanovir, saquinavir, nelfinavir, indinavir, or telithromycin.
  20. Use of CYP3A inducers, e.g. rifampin, phenytoin, carbamazepine and phenobarbital.
  21. Simvastatin or Lovastatin doses > 40 mg per day.
  22. Digoxin use.
  23. Receiving aspirin and physician and/or patient unwilling to reduce aspirin dose to <100 mg per day.
  24. Daily Non-steroidal anti-inflammatory drugs (NSAID) use as an outpatient (other than Aspirin (ASA) as above).
  25. Sick Sinus Syndrome, 2nd or 3rd degree heart block, bradycardia induced syncope - unless pacemaker in place.
  26. Otherwise unsuitable for participation in the opinion of the investigator (i.e., homeless, non-compliant, etc.).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01998399

  Show 26 Study Locations
Sponsors and Collaborators
Gordon Bernard
AstraZeneca
Investigators
Principal Investigator: Gordon R Bernard, MD Vanderbilt University Medical Center
Principal Investigator: Jon D Truwit, MD Medical College of Wisconsin
  More Information

Responsible Party: Gordon Bernard, Professor of Medicine, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01998399     History of Changes
Other Study ID Numbers: 131908
Study First Received: November 15, 2013
Results First Received: January 8, 2016
Last Updated: February 16, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Gordon Bernard, Vanderbilt University Medical Center:
CAP
Pneumonia
Intensive Care Unit
Mechanical Ventilation

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Ticagrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017