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The purpose of this study is to find the ideal range of the activated clotting time (ACT) during percutaneous coronary intervention (PCI) that is associated with lowering the rate of undesirable medical outcomes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low ACT Target | Active Comparator | ACT target range of 225 to 275 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used |
|
| Medium ACT Target | Active Comparator | ACT target range of 275 to 325 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used |
|
| High ACT Target | Active Comparator | ACT target range of 325 to 375 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unfractionated heparin | Drug | Administration of unfractionated heparin will be assessed using the activated clotting time |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding | Number of subjects to experience bleeding defined as Bleeding Academic Research Consortium (BARC) 1, 2, 3 or 5 or EASY hematoma classification after transradial/ulnar procedures (I-V) | From date of randomization until the date of first documented bleeding event up to 24 hours |
| Adverse Clinical Events | Number of subjects to experience a Net Adverse Clinical Event (NACE) defined as all-cause mortality, myocardial infarction, stroke, target lesion revascularization, or major bleeding | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Stent Thrombosis | Number of subjects to experience stent thrombosis | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shahyar M Gharacholou, MD, MSc | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Low ACT Target | ACT target range of 225 to 275 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time |
| FG001 | Medium ACT Target | ACT target range of 275 to 325 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time |
| FG002 | High ACT Target | ACT target range of 325 to 375 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Low ACT Target | ACT target range of 225 to 275 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time |
| BG001 | Medium ACT Target |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bleeding | Number of subjects to experience bleeding defined as Bleeding Academic Research Consortium (BARC) 1, 2, 3 or 5 or EASY hematoma classification after transradial/ulnar procedures (I-V) | Posted | Count of Participants | Participants | From date of randomization until the date of first documented bleeding event up to 24 hours |
|
Adverse events were collected from baseline to end of study participation for a total of approximately one month on all participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low ACT Target | ACT target range of 225 to 275 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vessel Closure | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shahyar M. Gharacholou | Mayo Clinic | 904-956-8400 | Gharacholou.Shahyar@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 20, 2020 | Mar 8, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| D000789 | Angina, Unstable |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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ACT target range of 275 to 325 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time |
| BG002 | High ACT Target | ACT target range of 325 to 375 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | High ACT Target | ACT target range of 325 to 375 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time |
|
|
| Primary | Adverse Clinical Events | Number of subjects to experience a Net Adverse Clinical Event (NACE) defined as all-cause mortality, myocardial infarction, stroke, target lesion revascularization, or major bleeding | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Stent Thrombosis | Number of subjects to experience stent thrombosis | Posted | Count of Participants | Participants | 30 days |
|
|
|
| 0 |
| 61 |
| 0 |
| 61 |
| 4 |
| 61 |
| EG001 | Medium ACT Target | ACT target range of 275 to 325 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time | 0 | 61 | 0 | 61 | 5 | 61 |
| EG002 | High ACT Target | ACT target range of 325 to 375 seconds is achieved prior to PCI if no planned glycoprotein IIb/IIIa inhibitor used Unfractionated heparin: Administration of unfractionated heparin will be assessed using the activated clotting time | 0 | 58 | 0 | 58 | 8 | 58 |
| Dissection | Surgical and medical procedures | Systematic Assessment |
|
| Spasm | Surgical and medical procedures | Systematic Assessment |
|
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| D001157 |
| Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D000787 | Angina Pectoris |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
| Male |
|