Ticagrelor in Severe Community Acquired Pneumonia (TCAP)
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| ClinicalTrials.gov Identifier: NCT01998399 |
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Recruitment Status :
Terminated
(poor enrollment, unable to meet recruitment goals)
First Posted : November 28, 2013
Results First Posted : March 11, 2016
Last Update Posted : December 11, 2017
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Sponsor:
Gordon Bernard
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Gordon Bernard, Vanderbilt University Medical Center
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Community Acquired Pneumonia, Severe | Drug: Ticagrelor Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 25 participants |
| 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 |
| Study Start Date : | August 2014 |
| Actual Primary Completion Date : | December 2015 |
| Actual Study Completion Date : | December 2015 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Pneumonia
Drug Information available for:
Ticagrelor
| Arm | Intervention/treatment |
|---|---|
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Experimental: Ticagrelor
Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days
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Drug: Ticagrelor
Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days
Other Name: Brilinta |
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Placebo Comparator: Placebo
Placebo 180 mg loading dose followed by 90 mg BID for 90 days.
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Drug: Placebo
Placebo 180 mg loading dose followed by 90 mg BID for 90 days. |
Primary Outcome Measures :
- All-cause Mortality [ Time Frame: 90 days ]death during 90 day study period
Secondary Outcome Measures :
- Shock Free Days [ Time Frame: 15 days ]Not requiring pressor support for hypotension
- Ventilator Free Days [ Time Frame: 29 days ]
- In-hospital Mortality [ Time Frame: Throughout hospitalization (About 2 weeks) ]Did the patient die during the hospitalization?
- Hospital Free Days [ Time Frame: 29 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?
- Stroke, Myocardial Infarct, Mortality [ Time Frame: 90 days ]number of participants that suffered stroke, myocardial infarct, mortality
- 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: 29 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 ]
- Need for Dialysis [ Time Frame: 28 days ]
- ICU Length of Stay [ Time Frame: 29 days ]Includes ICU readmission if during same hospital stay
- Hospital Length of Stay [ Time Frame: 29 days ]In days
- Discharge Disposition [ Time Frame: 90 days ](Home, other facility, with or without assisted ventilation)
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| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| 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:
- More than 72 hours have passed since meeting required inclusion criteria.
- Development of pneumonia after 72 hours of current hospitalization.
- Underlying disease likely to cause mortality within 90 days of randomization.
- A resident in a hospital, not nursing home, within 30 days prior to development of pneumonia.
- Patients who are moribund (not expected to live for more than 48 hours).
- No consent/inability to obtain consent from patient or surrogate.
- Patient's physician is unwilling to have patient enter the study.
- Age less than 50 years.
- Pregnancy.
- Breast feeding.
- Underlying immunodeficiency (e.g. HIV, neutropenia, active hematologic malignancy, functional or anatomical asplenia and hypogammaglobulinemia).
- 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).
- 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).
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Hepatic impairment
a. Child Pugh score > 7 using data from outpatient setting
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Conditions that increase the risk of bleeding, e.g.:
- 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);
- A history of severe head trauma requiring hospitalization or intra-cranial surgery within 3 months;
- 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;
- Gastrointestinal bleeding within 6 weeks before the study unless a corrective procedure has been performed;
- Recent trauma considered to increase the risk of bleeding.
- Chronic renal disease requiring renal replacement therapy.
- Creatinine > 3 mg/dL.
- Platelet count < 50,000 /mm3.
- 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.
- Use of CYP3A inducers, e.g. rifampin, phenytoin, carbamazepine and phenobarbital.
- Simvastatin or Lovastatin doses > 40 mg per day.
- Digoxin use.
- Receiving aspirin and physician and/or patient unwilling to reduce aspirin dose to <100 mg per day.
- Daily Non-steroidal anti-inflammatory drugs (NSAID) use as an outpatient (other than Aspirin (ASA) as above).
- Sick Sinus Syndrome, 2nd or 3rd degree heart block, bradycardia induced syncope - unless pacemaker in place.
- Otherwise unsuitable for participation in the opinion of the investigator (i.e., homeless, non-compliant, etc.).
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01998399
Locations
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 |
| Responsible Party: | Gordon Bernard, Professor of Medicine, Vanderbilt University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01998399 |
| Other Study ID Numbers: |
131908 |
| First Posted: | November 28, 2013 Key Record Dates |
| Results First Posted: | March 11, 2016 |
| Last Update Posted: | December 11, 2017 |
| Last Verified: | November 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by Gordon Bernard, Vanderbilt University Medical Center:
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CAP Pneumonia Intensive Care Unit Mechanical Ventilation |
Additional relevant MeSH terms:
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Pneumonia Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases Ticagrelor Platelet Aggregation Inhibitors |
Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |