Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03708588
Other study ID # 18-078_18-911
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 19, 2018
Est. completion date July 31, 2021

Study information

Verified date November 2022
Source Aurora Health Care
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Hypothesis The primary question the investigators propose to answer is whether all patients undergoing percutaneous coronary intervention (PCI) with stent deployment who receive chewed ticagrelor will demonstrate more rapid drug absorption and decreased platelet reactivity as compared to integral pill form 1 hour after drug administration.


Description:

Hypothesis The primary question the investigators propose to answer is whether all patients undergoing PCI with stent deployment who receive chewed ticagrelor will demonstrate more rapid drug absorption and decreased platelet reactivity as compared to integral pill form 1 hour after drug administration. Secondary Hypotheses: 1. Major adverse cardiac and cerebrovascular event (MACCE) rate at 30 days and 1 year. 1. Death 2. Repeat myocardial infarction 3. Need for urgent revascularization 4. Cerebrovascular accident 2. Rate of stent thrombosis and in-stent stenosis at 30 days and 1 year. 3. Bleeding: Defined as major, minor, or minimal bleeding based on thrombolysis in myocardial infarction (TIMI) criteria.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date July 31, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 89 Years
Eligibility Inclusion Criteria: • All patients presenting to the cardiac catheterization lab for percutaneous coronary intervention. Exclusion Criteria: - Age <18 years or Age >89 years - Known coagulopathy, bleeding diathesis, or active bleeding - History of recent gastrointestinal or genitourinary bleed within 2 months - Known chronic therapy with clopidogrel, prasugrel, or ticagrelor - Major surgery within last 6 weeks - History of intracranial bleed or intracranial neoplasm - Suspected aortic dissection - Severe hemodynamic instability, cardiogenic shock - Life expectancy <1 year - Known severe liver or renal disease - Known HIV treatment - Any use of Glycoprotein inhibitors (GP IIb-IIIa) 48-hours before the procedure or any use during the procedure - Any use of Cangrelor during or after the procedure - Hemoglobin <10 g/dL, platelet (PLT) <100x10^9/L - Pregnancy - Known allergy to study medication

Study Design


Related Conditions & MeSH terms

  • Percutaneous Coronary Intervention

Intervention

Drug:
Ticagrelor
Chewed
Ticagrelor
Integral

Locations

Country Name City State
United States Aurora Health Care, St. Luke's Medical Center Milwaukee Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
Aurora Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Concentration of Pharmacodynamics Platelet function was measured using the VerifyNow P2Y12 Assay (Accumetrics, San Diego, CA). This test is a turbidimetric-based optical detection system that measures ADP (Adenosine diphosphate) - induced platelet agglutination using a proprietary algorithm to report values in PRU. 1 hour
Secondary Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE) Measure events such as: death, repeat myocardial revascularization, cerebrovascular accident, stent thrombosis, in-stent stenosis and bleeding. 30 days
Secondary Number of Participants With Major Adverse Cardiac and Cerebrovascular Event (MACCE) Measure events such as: death, repeat myocardial revascularization, cerebrovascular accident, stent thrombosis, in-stent stenosis and bleeding. 1 year
See also
  Status Clinical Trial Phase
Terminated NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Not yet recruiting NCT05669222 - The FAVOR V AMI Trial N/A
Recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Recruiting NCT05240781 - Zotarolimus vs Sirolimus Eluting Stent in High Bleeding Risk N/A
Recruiting NCT03378934 - Anti-platelet Effect of Berberine in Patients After Percutaneous Coronary Intervention Phase 4
Not yet recruiting NCT06025071 - Residual Inflammatory Risk-Guided colcHicine in Elderly Trial Phase 4
Withdrawn NCT04043091 - Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction N/A
Completed NCT02837744 - Studying Hemostatic Effect of Axiostat® Dressing on Radial Access After Percutaneous Procedure
Completed NCT03085823 - The All-comers Sirolimus-coated Balloon European Registry
Completed NCT02044146 - A Pharmacodynamic Study of a Personalized Strategy for P2Y12 Inhibition Versus Ticagrelor in Reducing Ischemic and Bleeding Risk Phase 2/Phase 3
Completed NCT03131271 - Effect of Ice Bag Application to Femoral Region on Pain in Patients Undergoing Percutaneous Coronary Intervention N/A
Completed NCT01135667 - Prasugrel Versus Double Dose Clopidogrel to Treat Clopidogrel Low-responsiveness After PCI Phase 4
Completed NCT01156571 - A Clinical Trial Comparing Cangrelor to Clopidogrel Standard Therapy in Subjects Who Require Percutaneous Coronary Intervention (PCI) (CHAMPION PHOENIX) Phase 3
Unknown status NCT00751491 - Clopidogrel Versus Adenosin in Non Urgent Percutaneous Coronary Intervention (PCI) Phase 3
Completed NCT00725868 - Blood Endothelium Biomarkers to Predict Major Adverse Cardiovascular Events After Percutaneous Coronary Intervention N/A
Completed NCT04163393 - R-One Efficiency For PCI Evolution With Robotic Assistance N/A
Recruiting NCT05554588 - Intrathrombus Thrombolysis Versus Aspiration Thrombectomy During Primary PCI N/A
Recruiting NCT06080919 - Plaque Modification And Impact On Microcirculatory Territory After Drug-Coated Balloon Percutaneous Coronary Intervention (PLAMI). N/A
Recruiting NCT05353140 - LAAO Versus NOAC in Patients With AF and PCI N/A
Recruiting NCT06075433 - Evaluating Efficacy and Safety of 1-year of DAPT After Genoss DES Sirolimus-eluting Stent Implantation in Patients