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Excerpt TIMI 46 Acute Coronary Syndrome NCT00402597 - ATLAS ACS TIMI 46

- 17-09-21 - 1 Formulier, 66 Itemgroepen, 301 Data-elementen, 1 Taal
Itemgroepen: Subject Identification, Date of Visit, Demographics, Inclusion/Exclusion Criteria, Index ACS Event, Hospital Discharge for Index Event, Medical History of Special Interest, Vital Signs at Screening, Vital Signs, Physical Examination, Study Medication Review, First Dose of Study Medication, Concomitant Therapy, Aspirin Concomitant Therapy, Thienopyridine, Unfractionated Heparin, Low Molecular Weight Heparin, Parenteral Anticoagulant, Oral Anticoagulant, GP IIb/IIIa Inhibitor, Fibrinolytic, ECG, Unscheduled ECG, DNA Sample, DNA Sample Consent Modification, DNA Sample Replacement, Neurological Exam/Modified Rankin Scale, Seattle Angina Questionnaire, Echocardiogram, Holter, Medication Kit Number, Central Lab Sample Collection, PK/PD Sample Collection, End of Screening / Randomization, End of Treatment / Early Withdrawal, End of Follow-up, CEC Adjudicated Form, Death Adjudication, Myocardial Infarction, Severe Recurrent Ischemia Adjudication, Stroke Adjudication, NON-CNS Systemic Embolization Adjudication, Clinically Significant Bleeding Event Adjudication Form, Stent Thrombosis Adjudication, Canadian Cardiovascular Society Classification of Angina, Events and Procedures Review, Death, Cardiac Ischemic Events, Coronary Revascularization, Coronary Revascularization Prior to Signed Informed Consent, Local Cardiac Biomarker Measurements, Blood Transfusion, Stroke/TIA Events, Hemorrhage, Local Hematology Measurements, Non-CNS Systemic Embolization Events, Other Adverse Events, Local Lab, Health Resource Utilization Review, Emergency Room Visits, Hospitalization, Urgent Care or Physician Office Visit, Skilled Nursing/Rehabilitation Facility, Rehabilitation (Outpatient), Home Care Visits, Investigator Signature
ATLAS ACS-TIMI 46 compared the safety and efficacy of rivaroxaban, an oral direct factor Xa inhibitor, to placebo in patients with acute coronary syndromes. This is an excerpt, empty itemgroups have been added to flag missing items.

Excerpt PLATO Acute coronary Syndrome NCT00391872 - End of Treatment Visit

- 15-04-21 - 14 Formulieren, 10 Itemgroepen, 52 Data-elementen, 1 Taal
Itemgroepen: Visit, Clinical Events, Reminder, Procedures, Reminder, Overall Physical Examination, Vital Signs, Weight, Pregnancy Test, Electrocardiogram, NYHA - Heart Failure, EQ-5D Health-Related Quality of Life Questionnaire, Transition Antiplatelet Treatment
Ticagrelor is a new, reversible binding, anti-platelet medication. Anti-platelet medications work to prevent the formation of blood clots. Ticagrelor is being developed as a treatment for patients with acute coronary syndrome (ACS). ACS is a term that is used to describe both heart attacks in progress or the imminent threat of a heart attack. ACS is usually caused by the formation of a blood clot in an artery that partially or totally blocks the blood supply to a portion of the heart muscle. Ticagrelor will be compared with clopidogrel to determine which drug, when either is used in conjunction with aspirin, is better at reducing deaths from vascular causes, future heart attacks and/or strokes in patients with ACS. https://clinicaltrials.gov/ct2/show/NCT00391872

Section Investigational Products

5 Itemgroepen 4 Data-elementen

Unscheduled Visit

6 Itemgroepen 40 Data-elementen

Visit 4

5 Itemgroepen 39 Data-elementen

Visit 2

6 Itemgroepen 37 Data-elementen

Section Medication

2 Itemgroepen 2 Data-elementen

Follow-up Visit

4 Itemgroepen 33 Data-elementen

Eligibility ACCOAST Acute Coronary Syndrome NCT01015287 - Eligibility criteria

- 14-04-21 - 1 Formulier, 2 Itemgroepen, 15 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
The purpose of this trial is to investigate the potential benefits/risks regarding pretreatment with prasugrel in non-ST-elevation myocardial infarction (NSTEMI) participants with elevated troponin scheduled for coronary angiography/percutaneous coronary intervention (PCI). https://clinicaltrials.gov/ct2/show/NCT01015287

Input Data Elements CDSS Acute Coronary Syndrome or Myocardial Infarction Management Strauss 2014

- 13-10-16 - 1 Formulier, 1 Itemgroep, 9 Data-elementen, 1 Taal
Itemgroep: Risk assessment criteria
Input Data Elements CDSS for Acute Coronary Syndrome or Myocardial Infarction Management to evaluate impact of a real-time decision support to guide percutaneous PCI bleeding avoidance strategies. Published by Strauss et al. 2014

Input Data Elements CDSS Acute Coronary Syndrome or Myocardial Infarction Management Milani 2012

- 10-10-16 - 1 Formulier, 1 Itemgroep, 5 Data-elementen, 1 Taal
Itemgroep: Risk factors
Input Data Elements CDSS for Acute Coronary Syndrome or Myocardial Infarction Management to evaluate computer assisted decision support enhancing the likelihood of perfect care in acute coronary syndrome. Published by Milani et al. 2012

Eligibility TIMACS Acute Coronary Syndrome NCT00552513 - Eligibility Criteria

- 21-11-15 - 1 Formulier, 2 Itemgroepen, 10 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
The timing of intervention study is a prospective, randomized, international, multicentre comparison of the relative efficacy, safety, and cost effectiveness of a management strategy of coronary angiography and intervention performed within 24 hours of randomization versus delayed coronary angiography and intervention in patients after 36 hours with acute coronary syndromes (ACS). https://clinicaltrials.gov/ct2/show/NCT00552513

Eligibility MEDICATION Acute Coronary Syndrome NCT00903032 - Eligibility Criteria

- 21-11-15 - 1 Formulier, 2 Itemgroepen, 6 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
We propose to test the effectiveness of a multi-faceted patient-centered adherence intervention among veterans following ACS hospitalization to improve adherence to cardioprotective medications (primary aim). Secondary aims will assess whether the intervention improves achievement of secondary prevention blood pressure (BP) and low density lipoprotein (LDL)-cholesterol goals, reduces cardiac endpoints (myocardial infarction ) MI hospitalization, coronary revascularization, all-cause mortality) and is cost-effective. https://clinicaltrials.gov/ct2/show/NCT00903032

Eligibility Mojito Study Acute Coronary Syndrome NCT01992523 - Eligibility Criteria

- 21-11-15 - 1 Formulier, 2 Itemgroepen, 29 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
The aim of the Mashed Or Just Integral pill of TicagrelOr (MOJITO) study is to evaluate the superiority of Ticagrelor 180 mg LD mashed pill versus Ticagrelor 180 mg LD integral pill both orally administrated in decreasing residual platelet reactivity 1 hour after the administration among 70 patients with STEMI (ST segment elevation myocardial infarction) undergoing PPCI (primary percutaneous coronary intervention) with bivalirudin monotherapy. https://clinicaltrials.gov/ct2/show/NCT01992523

Eligibility Chest Pain Diagnostic Acute Coronary Syndrome NCT01035047 - Eligibility Criteria

- 21-11-15 - 1 Formulier, 2 Itemgroepen, 22 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion criteria
Clinical decision units (CDUs) improve resource utilization and are a recommended care option by the American College of Cardiology / American Heart Association, but are underutilized in non-low risk chest pain patients due to weaknesses of traditional cardiac testing. Cardiac magnetic resonance imaging (CMR) is sensitive and specific for ischemia, can simultaneously assess cardiac function and myocardial perfusion, and could revolutionize the diagnostic process for intermediate risk patients with chest pain. The primary objective of this trial is to measure the efficiency and safety of a combined CDU-CMR care pathway compared to inpatient care among patients with non-low risk acute chest pain. https://clinicaltrials.gov/ct2/show/NCT01035047

Eligibility RE-DEEM Acute Coronary Syndrome NCT00621855 - Eligibility criteria

- 21-11-15 - 1 Formulier, 2 Itemgroepen, 10 Data-elementen, 1 Taal
Itemgroepen: Inclusion criteria, Exclusion criteria
The purpose of this trial is to evaluate the safety and indicators of efficacy of up to 4 doses of orally administered dabigatran etexilate, administered twice daily, compared to placebo when given in addition to dual antiplatelet treatment in patients with an index event (MI) at high risk for new ischaemic cardiovascular events. https://www.clinicaltrials.gov/ct2/show/NCT00621855

Eligibility Ticagrelor Versus Clopidogrel Acute Coronary Syndrome NCT01294462 - Eligibility criteria

- 21-11-15 - 1 Formulier, 2 Itemgroepen, 7 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion criteria
The purpose of the study is to assess the efficacy (prevention of vascular events) and safety (especially bleedings) of Ticagrelor (AZD6140) compared with Clopidogrel, both given on top of low dose aspirin, in Asian/Japanese patients with acute coronary syndrome and a planned percutaneous coronary intervention (PCI). https://clinicaltrials.gov/ct2/show/NCT01294462

Eligibility Vorapaxar Acute Coronary Syndrome NCT00684203 - Eligibility criteria

- 21-11-15 - 1 Formulier, 2 Itemgroepen, 28 Data-elementen, 1 Taal
Itemgroepen: Inclusion Criteria, Exclusion Criteria
The study is designed to assess safety and effects of vorapaxar, when added to standard of care (aspirin and clopidigrel), in Japanese subjects with acute coronary syndrome. The study may also provide information about the effect of vorapaxar on preventing heart attack and stroke in this subject population. https://clinicaltrials.gov/ct2/show/NCT00684203

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